Trial Outcomes & Findings for Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment (NCT NCT05411991)
NCT ID: NCT05411991
Last Updated: 2025-08-08
Results Overview
The net treatment benefit is calculated for the hierarchical composite primary endpoint. Every patient from the intervention group is pair-wise compared with each patient from the control group to declare a winner or tie. The following criteria are sequentially assessed to declare a winner or a tie: 1. Any subject surviving until 30 days after randomization wins from a subject who died. If both subjects did not survive until day 30, there is a tie. 2. In a pair of subjects, both surviving up till day 30, the subject with the highest number of days alive and out of hospital or care facility during the 30-day follow-up window is declared the winner. 3. In a pair of subjects, both surviving up till day 30 with the same number of days alive and out of hospital/care facility, the subject with the greatest relative reduction in NTproBNP from baseline is the winner (rounded to the closest percentage with a minimal difference of 5%). If the difference is \<5%, there is a tie.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
107 participants
Primary outcome timeframe
30 days
Results posted on
2025-08-08
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
|
Overall Study
COMPLETED
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Diuretic Treatment in Acute Heart Failure With Volume Overload Guided by Serial Spot Urine Sodium Assessment
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=52 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
81 years
STANDARD_DEVIATION 10 • n=99 Participants
|
79 years
STANDARD_DEVIATION 10 • n=107 Participants
|
80 years
STANDARD_DEVIATION 10 • n=206 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
NTproBNP (ng/L)
|
4134 ng/L
n=99 Participants
|
4989 ng/L
n=107 Participants
|
4622 ng/L
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe net treatment benefit is calculated for the hierarchical composite primary endpoint. Every patient from the intervention group is pair-wise compared with each patient from the control group to declare a winner or tie. The following criteria are sequentially assessed to declare a winner or a tie: 1. Any subject surviving until 30 days after randomization wins from a subject who died. If both subjects did not survive until day 30, there is a tie. 2. In a pair of subjects, both surviving up till day 30, the subject with the highest number of days alive and out of hospital or care facility during the 30-day follow-up window is declared the winner. 3. In a pair of subjects, both surviving up till day 30 with the same number of days alive and out of hospital/care facility, the subject with the greatest relative reduction in NTproBNP from baseline is the winner (rounded to the closest percentage with a minimal difference of 5%). If the difference is \<5%, there is a tie.
Outcome measures
| Measure |
Intervention Arm
n=52 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Mortality, Days in Hospital & Decongestion
|
54.68 % wins
|
44.16 % wins
|
SECONDARY outcome
Timeframe: 30 daysNumber of patients with doubling of the serum creatinine or plasma cystatin C value compared to baseline with an absolute value \>2 mg/dL or \>2 mg/L, respectively, or the need for ultrafiltration and/or renal replacement therapy during the index hospital admission.
Outcome measures
| Measure |
Intervention Arm
n=52 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Renal Safety Endpoint
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of patients with a ystolic blood pressure \<90 mmHg or mean arterial pressure \<65 mmHg or need for vasopressors and/or inotropes during the index hospital admission.
Outcome measures
| Measure |
Intervention Arm
n=52 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Hemodynamic Safety Endpoint
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint could not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). In addition, 1 patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but no blood sample was available for this patient. Finally, 5 blood samples were missing in the control group because patients were unable to physically attend the final follow-up visit.
Relative NT-proBNP change from baseline to 30 days after randomisation \[%\].
Outcome measures
| Measure |
Intervention Arm
n=48 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=42 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Natriuretic Peptide Change After 30 Days
|
-37 % of change from baseline
Standard Deviation 64
|
-46 % of change from baseline
Standard Deviation 40
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint could not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). In addition, 1 patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but no blood sample was available for this patient. Finally, 5 blood samples were missing in the control group because patients were unable to physically attend the final follow-up visit.
Relative cancer antigen 125 (CA125) change from baseline to 30 days after randomisation \[%\].
Outcome measures
| Measure |
Intervention Arm
n=48 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=42 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Cancer Antigen 125 (CA125) Change After 30 Days
|
-69 % of change from baseline
Standard Deviation 40
|
-21 % of change from baseline
Standard Deviation 68
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm). One edema score was missing in the control group and could not be retrieved, precluding the assessment of decongestion success.
Number of participants with no more than trace edema, absence of jugular venous distension and no rales upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol.
Outcome measures
| Measure |
Intervention Arm
n=49 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=46 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Number of Participants With Successful Clinical Decongestion
|
33 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm).
Number of consecutive days from randomization during the index admission on which intravenous diuretic therapy was administered.
Outcome measures
| Measure |
Intervention Arm
n=49 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=47 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Length of Intravenous Diuretic Therapy
|
4 days
Interval 3.0 to 5.0
|
4 days
Interval 3.0 to 6.5
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint could not be assessed in patients who died before switching to oral diuretics (n=1 in the intervention group and n=3 in the control group).
Five-point Likert scale for overall well-being upon the moment of transition from intravenous diuretics to oral diuretic therapy according to the protocol and compared with the moment of randomisation (5: much improved/4: slightly improved/3: neutral/2: slightly worse/1: much worse).
Outcome measures
| Measure |
Intervention Arm
n=51 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=48 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Overall Well-being After Decongestion
Significantly worse
|
0 Participants
|
0 Participants
|
|
Overall Well-being After Decongestion
Worse
|
3 Participants
|
0 Participants
|
|
Overall Well-being After Decongestion
Unchanged
|
3 Participants
|
4 Participants
|
|
Overall Well-being After Decongestion
Better
|
28 Participants
|
35 Participants
|
|
Overall Well-being After Decongestion
Significantly better
|
17 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: This endpoint was not be assessed in patients who died (n=3 in the intervention arm and n=4 in the control arm).
Length of the index hospital admission \[days\].
Outcome measures
| Measure |
Intervention Arm
n=49 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=47 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Length of the Index Hospital Admission
|
7 days
Interval 5.0 to 9.0
|
7 days
Interval 5.0 to 10.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: One patient in the intervention arm withdrew consent during follow-up. Vital status could be assessed, but not data on hospitalizations or medical contacts. Therefore the overall number of participants analyzed is 1 lower than for the primary endpoint.
Number of participants who are death, or have a non-elective hospital admission or non-elective medical contact
Outcome measures
| Measure |
Intervention Arm
n=51 Participants
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 Participants
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Number of Participants Who Are Death, or Have a Non-elective Hospital Admission or Non-elective Medical Contact
|
9 Participants
|
12 Participants
|
Adverse Events
Intervention Arm
Serious events: 6 serious events
Other events: 13 other events
Deaths: 3 deaths
Control Arm
Serious events: 14 serious events
Other events: 21 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intervention Arm
n=52 participants at risk
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 participants at risk
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
3.8%
2/52 • Number of events 2 • 30 days
|
5.9%
3/51 • Number of events 3 • 30 days
|
|
Cardiac disorders
Worsening heart failure
|
1.9%
1/52 • Number of events 1 • 30 days
|
13.7%
7/51 • Number of events 7 • 30 days
|
|
Cardiac disorders
Urgent electrical cardioversion of atrial fibrillation
|
1.9%
1/52 • Number of events 1 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
|
Cardiac disorders
Symptomatic bradycardia
|
0.00%
0/52 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
|
Infections and infestations
Endocarditis
|
1.9%
1/52 • Number of events 1 • 30 days
|
0.00%
0/51 • 30 days
|
|
Renal and urinary disorders
Hyperkalaemia
|
0.00%
0/52 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
|
Endocrine disorders
Hypocalcemia
|
1.9%
1/52 • Number of events 1 • 30 days
|
0.00%
0/51 • 30 days
|
|
Cardiac disorders
Need for vasopressor
|
0.00%
0/52 • 30 days
|
2.0%
1/51 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Intervention Arm
n=52 participants at risk
Application of a standardized diuretic schedule with following key components:
* Serial post-diuretic spot urine sodium (UNa) assessment
* Loop diuretic dosing according to estimated glomerular filtration rate (eGFR)
* Upfront use of intravenous acetazolamide 500 mg OD
* Upfront use of oral chlorthalidone 50 mg OD if eGFR \<30 mL/min/1.73m² OR hypernatremia
* Full nephron blockade for diuretic resistance
* Provision of 500 mL intravenous Dextrose 5% with 3 g MgSO4 and 40 mmol KCl daily during intravenous diuretics
|
Control Arm
n=51 participants at risk
Usual care for AHF. It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines. Urine electrolyte assessment in the control arm is not allowed as it is a key component of the studied intervention.
Usual AHF care: It is recommended to administer an intravenous loop diuretic dose at least BID (or through continuous infusion), with the aim of achieving a urine output 3-5 L per day until the patient is considered in an optimal volume status as is recommended by current guidelines.
|
|---|---|---|
|
Renal and urinary disorders
Hypokalaemia
|
25.0%
13/52 • Number of events 13 • 30 days
|
41.2%
21/51 • Number of events 21 • 30 days
|
Additional Information
Prof. Dr. Frederik H. Verbrugge
University Hospital Brussels - Vrije Universiteit Brussel
Phone: 024749657
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place