Trial Outcomes & Findings for Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: (NCT NCT04501861)
NCT ID: NCT04501861
Last Updated: 2025-03-24
Results Overview
The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure
COMPLETED
PHASE3
153 participants
during 20 minute period after chest closure
2025-03-24
Participant Flow
This is a unblinded alternating trial. The treatment will be randomized in one week blocks and not by patient, using the RedCap system. This means that during any week, eligible patients will be exposed to the same vasopressor agent (vasopressin or norepinephrine). And the following week there will be new randomization in place. Allocations will be directly communicated to anesthesia personnel and by signs prominently displayed in anesthesia ready room.
Participant milestones
| Measure |
The Use of Vasopressin
This group including patients who received vasopressin on the pulmonary circulation in cardiac surgery.
|
The Use of Norepinephrine
This group including patients who received norepinephrine on the pulmonary circulation in cardiac surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
83
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
70
|
83
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:
Baseline characteristics by cohort
| Measure |
Patients Using Intraoperative Vasopressin
n=70 Participants
Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
|
Patients Using Intraoperative Norepinephrine
n=83 Participants
Hemodynamic effect of Norepinephrine on the pulmonary circulation in cardiac surgery patients
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 12 • n=99 Participants
|
66 years
STANDARD_DEVIATION 13 • n=107 Participants
|
66 years
STANDARD_DEVIATION 13 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
103 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
70 Participants
n=99 Participants
|
83 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
BMI
|
29 kg/m^2
STANDARD_DEVIATION 6 • n=99 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 6.5 • n=107 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 6.5 • n=206 Participants
|
|
Comorbid conditions
Hypertension
|
53 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Comorbid conditions
Coronary artery disease
|
49 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
110 Participants
n=206 Participants
|
|
Comorbid conditions
Diabetes
|
21 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Comorbid conditions
Chronic kidney disease
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Comorbid conditions
Peripheral artery disease
|
9 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Comorbid conditions
Cerebral vascular disease
|
12 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Comorbid conditions
Congestive heart failure
|
30 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Comorbid conditions
Smoking history
|
34 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
Comorbid conditions
Hyperlipidemia
|
42 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Comorbid conditions
Pulmonary hypertension
|
19 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Preoperative RV dysfunction
Normal
|
50 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
|
Preoperative RV dysfunction
Mild
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Preoperative RV dysfunction
Moderate or severe
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Surgery type
Aortic valve surgery
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Surgery type
Aortic surgery
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Surgery type
CABG + aortic valve surgery
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Surgery type
CABG + mitral valve surgery
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Surgery type
Isolated CABG
|
10 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Surgery type
Mitral valve surgery
|
4 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Surgery type
Multi-valve procedures
|
18 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Surgery type
Other
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Primary or repeat surgery
Primary surgery
|
38 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
88 Participants
n=206 Participants
|
|
Primary or repeat surgery
Reoperative surgery
|
32 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: during 20 minute period after chest closurePopulation: Not all the patients in the 2 groups with preoperative pulmonary arterial hypertension, we only included the eligible patients.
The intraoperative mean pulmonary artery pressure(mPAP) adjusted for systemic mean arterial pressure(MAP), using a time-weighted average mPAP-to-MAP ratio measured during 20 minute period after chest closure
Outcome measures
| Measure |
The Use of Vasopressin
n=70 Participants
Vasopressin (20 IU/100 ml in 5% dextrose) was stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps
Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
|
The Use of Norepinephrine
n=83 Participants
Norepinephrine (4 mg/250ml in 5% dextrose) was stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps
Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
|
|---|---|---|
|
mPAP-to-MAP Ratio
mPAP-to-MAP ratio
|
0.394 ratio of mPAP-to-MAP
Standard Deviation 0.086
|
0.385 ratio of mPAP-to-MAP
Standard Deviation 0.094
|
|
mPAP-to-MAP Ratio
mPAP-to-MAP ratio with preop pulmonary hypertension
|
0.42 ratio of mPAP-to-MAP
Standard Deviation 0.082
|
0.40 ratio of mPAP-to-MAP
Standard Deviation 0.093
|
|
mPAP-to-MAP Ratio
mPAP-to-MAP ratio without preop pulmonary hypertension
|
0.37 ratio of mPAP-to-MAP
Standard Deviation 0.084
|
0.36 ratio of mPAP-to-MAP
Standard Deviation 0.092
|
SECONDARY outcome
Timeframe: during 20 minutes period after chest closurePopulation: Included all patients for RV free wall strain. As not all the patients with/without preoperative pulmonary arterial hypertension, so the study pop in subgroup are different.
Right Ventricular Free Wall Longitudinal Strain (RV FWLS) is a measure of the deformation (strain) of the right ventricle's free wall (the part not attached to the septum) during contraction. It quantifies how much the myocardium in the free wall of the right ventricle shortens along its longitudinal axis (base to apex) during systole (contraction). It is expressed as a negative percentage (%), where more negative values indicate better contractility (e.g., -20% is better than -10%). In this study, it was measured by transesophageal echocardiography in the 2D mid-esophageal four-chamber view during a steady state period after chest closure
Outcome measures
| Measure |
The Use of Vasopressin
n=70 Participants
Vasopressin (20 IU/100 ml in 5% dextrose) was stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps
Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
|
The Use of Norepinephrine
n=83 Participants
Norepinephrine (4 mg/250ml in 5% dextrose) was stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps
Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
|
|---|---|---|
|
RV Free Wall Strain
RV free wall strain
|
-18.2 percentage of RV free wall strain
Standard Deviation 8.4
|
-19.4 percentage of RV free wall strain
Standard Deviation 7.2
|
|
RV Free Wall Strain
RV free wall strain with preop pulmonary hypertension
|
-17.5 percentage of RV free wall strain
Standard Deviation 8.4
|
-18.9 percentage of RV free wall strain
Standard Deviation 8.1
|
|
RV Free Wall Strain
RV free wall strain without preop pulmonary hypertension
|
-19.2 percentage of RV free wall strain
Standard Deviation 8.4
|
-20.0 percentage of RV free wall strain
Standard Deviation 5.7
|
Adverse Events
The Use of Vasopressin
The Use of Norepinephrine
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