Trial Outcomes & Findings for Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction (NCT NCT04919564)
NCT ID: NCT04919564
Last Updated: 2024-01-05
Results Overview
Glomerular Filtration Rate measured at baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
baseline / before induction to anesthesia
Results posted on
2024-01-05
Participant Flow
Participant milestones
| Measure |
Furosemide
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Furosemide
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
Baseline Characteristics
Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Baseline characteristics by cohort
| Measure |
Furosemide
n=45 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=45 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 7 • n=99 Participants
|
57 years
STANDARD_DEVIATION 8 • n=107 Participants
|
58 years
STANDARD_DEVIATION 8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
71 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
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
|
Weight
|
68.7 kilogram
STANDARD_DEVIATION 10.7 • n=99 Participants
|
66.7 kilogram
STANDARD_DEVIATION 16 • n=107 Participants
|
67.7 kilogram
STANDARD_DEVIATION 13.5 • n=206 Participants
|
|
Height
|
161.6 centimeter
STANDARD_DEVIATION 7.93 • n=99 Participants
|
160.6 centimeter
STANDARD_DEVIATION 7.4 • n=107 Participants
|
161.2 centimeter
STANDARD_DEVIATION 7.64 • n=206 Participants
|
|
Type of operation
CABG
|
36 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Type of operation
Valve surgery
|
8 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Type of operation
CABG + Valve Surgery
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
percentage of Left Ventricular ejection fraction
|
56.91 %
STANDARD_DEVIATION 9.48 • n=99 Participants
|
54.93 %
STANDARD_DEVIATION 9.68 • n=107 Participants
|
55.92 %
STANDARD_DEVIATION 9.58 • n=206 Participants
|
|
percentage of patient with pre-operation Comorbid
score 1-2 (mild condition)
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
percentage of patient with pre-operation Comorbid
score 3-4 (moderate condition)
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
percentage of patient with pre-operation Comorbid
score >5 (severe condition)
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
patient with history of daily use of ACEI/ARB
history of ACE-i/ARB
|
30 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
patient with history of daily use of ACEI/ARB
no history of ACE-i/ARB
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
patient with history of daily use of Diuretic
History of Diuretics
|
19 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
patient with history of daily use of Diuretic
no History of Diuretics
|
26 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
percentage of patient with pre operation renal Dysfunction
mildly impaired
|
22 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
percentage of patient with pre operation renal Dysfunction
moderately impaired
|
23 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: baseline / before induction to anesthesiaGlomerular Filtration Rate measured at baseline
Outcome measures
| Measure |
Furosemide
n=45 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=45 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Glomerular Filtration Rate at Baseline
|
56 mL/mnt/1.73 m^2
Interval 30.0 to 88.0
|
67 mL/mnt/1.73 m^2
Interval 35.0 to 89.0
|
PRIMARY outcome
Timeframe: 12 hours from drug infusionGlomerular Filtration Rate measured at 12 hours from the initiation of drug infusion
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Glomerular Filtration Rate at 12 Hours From Drug Infusion
|
45 mL/mnt/1.73 m^2
Interval 14.0 to 84.0
|
46 mL/mnt/1.73 m^2
Interval 19.0 to 99.0
|
PRIMARY outcome
Timeframe: 24 hours after from infusionGlomerular Filtration Rate measured at 24 hours from the initiation of drug infusion
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Glomerular Filtration Rate at 24 Hours From Drug Infusion
|
39.5 mL/mnt/1.73 m^2
Interval 21.0 to 87.0
|
38 mL/mnt/1.73 m^2
Interval 10.0 to 73.0
|
PRIMARY outcome
Timeframe: 48 hours from drug infusionGlomerular Filtration Rate measured at 48 hours from the initiation of drug infusion
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Glomerular Filtration Rate at 48 Hours From Drug Infusion
|
41 mL/mnt/1.73 m^2
Interval 15.0 to 89.0
|
41.5 mL/mnt/1.73 m^2
Interval 9.0 to 84.0
|
PRIMARY outcome
Timeframe: 120 hours from drug infusionGlomerular Filtration Rate measured at 120 hours from the initiation of drug infusion
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Glomerular Filtration Rate at 120 Hours From Drug Infusion
|
49 mL/mnt/1.73 m^2
Interval 22.0 to 103.0
|
50 mL/mnt/1.73 m^2
Interval 15.0 to 98.0
|
PRIMARY outcome
Timeframe: 28 days (or until hospital discharge)number of participants with Therapeutic Dose of Continuous Diuretic Infusion
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Therapeutic Dose of Continuous Diuretic Infusion
|
10 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 28 days (or until hospital discharge)number of participant with Renal Replacement Therapy
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
Renal Replacement Therapy
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 28 days (or until hospital discharge)The length of stay in ICU
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
ICU Length of Stay
|
27 hours
Interval 13.0 to 340.0
|
24 hours
Interval 9.0 to 384.0
|
SECONDARY outcome
Timeframe: 28 days (or until hospital discharge)number of In Hospital mortality
Outcome measures
| Measure |
Furosemide
n=43 Participants
Low dose continuous furosemide 2 mg/hour for a period of 12 hours since anesthetic induction
Furosemide: Furosemide 2 mg/hour for 12 hours since induction
|
Control
n=44 Participants
NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
Control: NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
|
|---|---|---|
|
In Hospital Mortality
|
1 Participants
|
1 Participants
|
Adverse Events
Furosemide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Prieta Adriane, MD
National Cardiovascular Center Harapan Kita Jakarta
Phone: +62 852-2004-0006
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place