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Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients

NCT06265259 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-03-06

No results posted yet for this study

Summary

Current guidelines recommend the inititaion of noradrenaline and if shock is refractory, then vasopressin should be administered. Data indicate that the earlier use of vasopressin may improve survival. Two large randomized controlled trial failed to prove a survival benefit from the early use of vasopressin. The present study will investigate the effect of an early initiation protocol of vasopressin (as the first vasoconstrictor drug) on the degree of multiorgan failure improvement and also on the course of sepsis (if in septic patients) versus early initiation of noradrenaline as first vasoconstrictor drug in hemodynamically unstable patients.

Conditions

  • Circulatory Shock

Interventions

DRUG

Initiation of vasopressine as a first vasoconstrictive drug

The group (arm 1) where vasopressin (1 amp in 50 mlN/S) (1st vasoconstrictor) will be administered first up to a maximum dose of 0.03 IU/min (2.3 ml/h) for the treatment of hemodynamic instability. Then, if the patient remains unstable, noradrenaline (2nd vasoconstrictor) will be started. The dose of vasopressin will not be increased further than the above mentioned limit.

DRUG

Initiation of noradrenaline as a first vasoconstrictive drug

ii. In the group (arm 2) where the treatment of haemodynamic instability will be performed by first administering noradrenaline (1st vasoconstrictor) up to 0,5 mcg/kg/min and then, if the patient is still unstable, adding vasopressin (2nd vasoconstrictor) at a maximum dose of 0.03 IU/min (2.3ml/h). If haemodynamic instability persists, treatment will involve further increase of the noradrenaline dose.

Sponsors & Collaborators

  • University of Thessaly

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06265259 on ClinicalTrials.gov