Trial Outcomes & Findings for Atrial Natriuretic Peptide in Assessing Fluid Status (NCT NCT05070819)
NCT ID: NCT05070819
Last Updated: 2025-06-08
Results Overview
To assess the atria strain and consequent rise of pro-ANP by the end of surgery
COMPLETED
NA
30 participants
intraoperatively
2025-06-08
Participant Flow
Participant milestones
| Measure |
Cardiac Surgery Patients
1. After admission to OR and arterial catheter is placed the pro-ANP probe is obtained.
2. After anesthesia induction, trachea intubation before Teboul' test pro-ANP is obtained
3. At the end of Teboul' test when lower limbs are lifted
4. 30 minutes of CPB
5. End of CPB
6. End of volume transition from CPB circuit to patient
7. Before Teboul' test at the end of surgery
8. End of Teboul' test when lower limbs are lifted
pro-ANP: pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atrial Natriuretic Peptide in Assessing Fluid Status
Baseline characteristics by cohort
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 13 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Russia
|
30 participants
n=99 Participants
|
|
Body surface area, м²
|
2 square meters
STANDARD_DEVIATION 0.23 • n=99 Participants
|
PRIMARY outcome
Timeframe: intraoperativelyTo assess the atria strain and consequent rise of pro-ANP by the end of surgery
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Number of Patients With Pro-ANP Twofold Raise by the End of Surgery
|
17 Participants
|
PRIMARY outcome
Timeframe: intraoperativeAccording to positive PLR the assessment of pro-ANP consequent raise
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver
|
5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes of PLR testUsing Massimo vigileo hard- and software the first assessment of cardiac index was made before Teboul test after the trachea intubation. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver
|
5 Responders
|
PRIMARY outcome
Timeframe: 10 minutes of PLR testUsing Massimo vigileo hard- and software the assessment of cardiac index was made before Teboul test at the end of surgery before leaving the operating room. After 10 minutes of passive leg raising maneuver second assessment. If raise in cardiac index above 10 percent was detected the patient was considered a responder. If not - non-responder.
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery
|
8 Responders
|
SECONDARY outcome
Timeframe: up to 10 daysTotal amount of various postoperative complications
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Postoperative Complications
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysMortality rate
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Mortality
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNumber of more than 2 organs failure
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Multiorgan Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNumber of patients who require prolonged and/or repeated artificial lung ventilation
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Respiratory Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNumber of patients who require extracorporeal detoxication
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Renal Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNeed in medicamental cardiotonic support more than 1 day
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Heart Failure
|
1 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNeed in medicamental vasopressor support more than 1 day
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Circulatory Insufficiency
|
3 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysNumber of patients who develop systemic infection and/or operation wound infection
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Infection Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysDuration of summarized length in ICU, including readmission to ICU
Outcome measures
| Measure |
Cardiac Surgery Patients
n=30 Participants
30 patients enrolled in a study
|
|---|---|
|
Length of Intensive Care Stay
|
22 hours
Interval 19.0 to 23.0
|
Adverse Events
Cardiac Surgery Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place