Trial Outcomes & Findings for Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients: (NCT 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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

153 participants

Primary outcome timeframe

during 20 minute period after chest closure

Results posted on

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

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

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=5 Participants	66 years STANDARD_DEVIATION 13 • n=7 Participants	66 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	32 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	70 Participants n=5 Participants	83 Participants n=7 Participants	153 Participants n=5 Participants
BMI	29 kg/m^2 STANDARD_DEVIATION 6 • n=5 Participants	28.2 kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	28.5 kg/m^2 STANDARD_DEVIATION 6.5 • n=5 Participants
Comorbid conditions Hypertension	53 Participants n=5 Participants	66 Participants n=7 Participants	119 Participants n=5 Participants
Comorbid conditions Coronary artery disease	49 Participants n=5 Participants	61 Participants n=7 Participants	110 Participants n=5 Participants
Comorbid conditions Diabetes	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Comorbid conditions Chronic kidney disease	2 Participants n=5 Participants	7 Participants n=7 Participants	9 Participants n=5 Participants
Comorbid conditions Peripheral artery disease	9 Participants n=5 Participants	17 Participants n=7 Participants	26 Participants n=5 Participants
Comorbid conditions Cerebral vascular disease	12 Participants n=5 Participants	24 Participants n=7 Participants	36 Participants n=5 Participants
Comorbid conditions Congestive heart failure	30 Participants n=5 Participants	39 Participants n=7 Participants	69 Participants n=5 Participants
Comorbid conditions Smoking history	34 Participants n=5 Participants	43 Participants n=7 Participants	77 Participants n=5 Participants
Comorbid conditions Hyperlipidemia	42 Participants n=5 Participants	51 Participants n=7 Participants	93 Participants n=5 Participants
Comorbid conditions Pulmonary hypertension	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Preoperative RV dysfunction Normal	50 Participants n=5 Participants	63 Participants n=7 Participants	113 Participants n=5 Participants
Preoperative RV dysfunction Mild	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Preoperative RV dysfunction Moderate or severe	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Surgery type Aortic valve surgery	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Surgery type Aortic surgery	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Surgery type CABG + aortic valve surgery	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Surgery type CABG + mitral valve surgery	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Surgery type Isolated CABG	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Surgery type Mitral valve surgery	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Surgery type Multi-valve procedures	18 Participants n=5 Participants	33 Participants n=7 Participants	51 Participants n=5 Participants
Surgery type Other	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Primary or repeat surgery Primary surgery	38 Participants n=5 Participants	50 Participants n=7 Participants	88 Participants n=5 Participants
Primary or repeat surgery Reoperative surgery	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants

PRIMARY outcome

Timeframe: during 20 minute period after chest closure

Population: Not all the patients in the 2 groups with preoperative pulmonary arterial hypertension, we only included the eligible patients.

Outcome measures

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 closure

Population: 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The Use of Norepinephrine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mariya Geube

Cleveland Clinic Foundation

Phone: 216-444-2779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place