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

PHASE4RecruitingINTERVENTIONAL
Enrollment

350

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

July 30, 2025

Study Completion Date

July 30, 2025

Conditions
Vasoplegic Syndrome of Cardiac Surgery
Interventions
DRUG

Vasopressin intravenous infusion

Vasopressin will be administered intravenously in a blinded 250 mL bag of 5% glucose solution, at a final concentration of 0.12 U/mL. The infusion will begin at 5 mL/h and be increased by 2.5 mL/h every 10 minutes during the first hour, up to a maximum rate of 30 mL/h (equivalent to doses from 0.01 to 0.06 U/min). The target is to reach and maintain mean arterial pressure (MAP) ≥65 mmHg. If this is not achieved, open-label norepinephrine may be added. Hemodynamic and echocardiographic parameters will be measured before and after the target MAP is reached.

DRUG

Norepinephrine intravenous infusion

Norepinephrine will be administered intravenously in a blinded 250 mL bag of 5% glucose solution, at a final concentration of 120 µg/mL. The infusion will begin at 5 mL/h and be increased by 2.5 mL/h every 10 minutes during the first hour, up to a maximum rate of 30 mL/h (equivalent to doses from 10 to 60 µg/min). The goal is to reach and maintain MAP ≥65 mmHg. If the MAP target is not reached, open-label norepinephrine may be initiated. Clinical and hemodynamic parameters will be collected at baseline and after MAP stabilization.

Trial Locations (1)

05403-000

RECRUITING

Instituto do Coração HCFMUSP, São Paulo

All Listed Sponsors
collaborator

Hospital Universitário Cassiano Antônio de Moraes/HUCAM

UNKNOWN

collaborator

Hospital Santa Casa de Misericórdia de Vitória

UNKNOWN

lead

University of Sao Paulo

OTHER