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Systematic Adjunction of Vasopressine in Septic Shock

Plain-language guide to NCT07052084: phase 3 randomized trial of Vasopressin, 120 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07052084
Phase
phase 3
Status
not yet recruiting
Start
2026-01
Completion (planned or actual)
2028-02
Participants
120 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Septic Shock
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 3 trial, researchers set out to test Vasopressin.

In line with current recommendations, norepinephrine is the first-line vasopressor used in patients with septic shock.

It had two arms (groups): Vassopressine (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

120 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient aged 18 or over. Patient in septic shock with adapted cardiac output.

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: patient with acute coronary syndrome; patient with known history of acute coronary syndrome; patient with suspected mesenteric ischemia.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

The Vasopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-01 with completion listed for 2028-02.

It ran at 3 sites in France (3).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): SOFA score comparison between the two groups (time frame: 48 hours after administration of experimental drug (H48)).

It also tracked 12 secondary outcomes, for example SOFA score comparison between the two groups, Mortality comparison between the two groups, Noradrenaline use comparison between the two groups, Renal function comparison between the two groups, Respiratory function comparison between the two groups and Occurrence of myocardial ischemia comparison between the two groups.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 120 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.

Our Notes on the Compound

Vasopressin: A 9-amino-acid hormone (antidiuretic hormone) that controls water balance and blood vessel tone; used in septic shock.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.