Hemodynamic Effect of Norepinephrine Versus Vasopressin on the Pulmonary Circulation in Cardiac Surgery Patients:

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The relative increase in the mPAP with the same unit increase in MAP adjusted for baseline, and RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery

NCT01505231

Shock

UNKNOWN PHASE3

Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery

NCT04602767

Acute Kidney Injury

RECRUITING PHASE4

Inotropic Effects of Vasopressin Versus Noradrenaline In Patients With Vasoplegic Syndrome After Cardiac Surgery

NCT06934798

Vasoplegic Syndrome of Cardiac Surgery

RECRUITING PHASE4

The Effect of Vasopressors on Cerebral Oxygentaion During Off Pump CABG

NCT04214145

Cerebral Oxygen Saturation

COMPLETED NA

Phenylephrine and Pulse Pressure Variability

NCT05011357

Intraoperative Hypotension

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The specific aims of our study are to compare 1) the relative increase in the mPAP with the same unit increase in MAP adjusted for baseline and 2) RV function assessed by GLS, between VP and NE in patients with normal and increased pulmonary artery pressure, who require vasopressor support during cardiac surgery. We hypothesize that the use of vasopressin compared with norepinephrine induces a lower mPAP-to-MAP ratio, in cardiac surgical patients with and without pulmonary hypertension who require intraoperative vasopressor support. Second, we will test the hypothesis that vasopressin is associated with improved right ventricular global longitudinal strain compared to norepinephrine in patients requiring vasopressor support during cardiac surgery.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized cluster crossover study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

use of vasopressin

Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Norepinephrine (4 mg/250ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps

use of norepinephrine

Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients

Group Type ACTIVE_COMPARATOR

Vasopressin

Intervention Type DRUG

Vasopressin (20 IU/100 ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vasopressin

Vasopressin (20 IU/100 ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps

Intervention Type DRUG

Norepinephrine

Norepinephrine (4 mg/250ml in 5% dextrose) were stored in pre-mixed bags in the operating room, readily available for continuous infusion administration via pre-programed infusion pumps

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Adults\> 18 years of age

* Elective cardiac surgery with the use of CPB
* Patients with pulmonary artery catheter insertion
* Systemic hypotension (MAP \< 70 mmHg) requiring continuous infusion of vasopressor

Exclusion Criteria

* Transplant surgery
* Ventricular assist device implantation other than intra-aortic balloon counter-pulsation
* Pulmonary endarterectomy
* Thoracoabdominal aneurysm repair
* Inhalational pulmonary vasodilators (e.g. Epoprostenol) administration before insertion of pulmonary artery catheter
* Vasopressin is started as the first choice of pressor per clinical staff discretion

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No