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Renal Outcomes in the Early Use of Vasopressin in the Treatment of Septic Shock
Plain-language guide to NCT06471231: phase 4 randomized trial of Vasopressin, 264 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06471231
- Phase
- phase 4
- Status
- status unknown
- Start
- 2024-05-15
- Completion (planned or actual)
- 2026-05-15
- Participants
- 264 (estimated)
- Design
- randomized, single-blind, prevention
- Conditions studied
- Septic Shock; Renal Function Replacement
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Vasopressin.
It had two arms (groups): Group A (experimental) and Group B (active comparator).
The registry classes the interventions as drug.
More on the Plan
The study is aimed at patients admitted to the ICU with a diagnosis of septic shock on admission or in the first 24 hours of admission.
Who Took Part
264 planned participants were the target.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients suffering from septic shock hospitalized in an intensive setting. Patients over 18 years and under 80 years of age. Patients capable of expressing informed consent to treatment.
The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: patients in the absence of consent to participate in the study and to the processing of personal and particular data;; patients under 18 years of age or over 80 years of age;; patients with recent acute coronary syndrome (within the previous 7 days);.
How the Study Was Run
Design: randomized, parallel-group and single-blind.
Because people in this Vasopressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Vasopressin group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Vasopressin was given.
Those kept unaware of assignments: investigator.
It started in 2024-05-15 with completion listed for 2026-05-15.
It ran at 1 site in Italy.
Its stated primary purpose is prevention.
What Was Measured
It also tracked 8 secondary outcomes, for example rly addition of vasopressin modifies renal perfusion, addition of vasopressin modifies the fluid balance of patients, intestinal and/or digital and/or limb ischemia;, Length of stay in ICU and Mortality.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Vasopressin in 264 people.
Its status is unknown; 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.