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Early Versus Late Adjunctive Vasopressin in Septic Shock
Plain-language guide to NCT06709573: phase 4 randomized trial of Vasopressin, 300 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06709573
- Phase
- phase 4
- Status
- recruiting participants
- Start
- 2025-04-29
- Completion (planned or actual)
- 2027-05-01
- Participants
- 300 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Sepsis; Septic Shock
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Vasopressin.
It had two arms (groups): Early Vasopressin Initiation (experimental) and Standard of Care Vasopressin Initiation (active comparator).
The registry classes the interventions as drug.
More on the Plan
Patients with septic shock have persistent hypotension requiring vasoactive agents to augment blood pressure despite fluid resuscitation.
Norepinephrine is recommended first-line by the Surviving Sepsis Campaign (SSC) guidelines for patients with septic shock.
Yet, many questions remain regarding the timing of vasopressin initiation.
The goal of this proposal is to evaluate the timing of vasopressin initiation in patients with septic shock based on the norepinephrine requirements at the time of vasopressin initiation.
Who Took Part
300 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: Age ≥ 18 Years. Diagnosis of Septic Shock.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: administration of any other vasoactive agent other than norepinephrine at time of enrollment.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.
The Vasopressin group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.
Those kept unaware of assignments: participant and care provider.
It started in 2025-04-29 with completion listed for 2027-05-01.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Vasopressin in 300 people.
It is still 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.