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Comparison of Vasopressin and Other Pressors in Septic Shock

Plain-language guide to NCT00269685: phase 2, phase 3 randomized trial of Vasopressin, 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00269685
Phase
phase 2, phase 3
Status
completed
Start
2000-07
Completion (planned or actual)
n/a
Participants
20
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Shock, Septic
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2, phase 3 trial tested Vasopressin.

The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.

Vasopressin seems to be an interesting alternative in the treatment of septic shock.

The registry classes the interventions as drug.

Who Took Part

20 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: Legally major patient presenting a septic shock.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: shock other than septic; cardiac hypokinesia; a pre-existing organic renal failure that needs hemodyalisis.

How the Study Was Run

Design: randomized, single-group and open-label.

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

Being open-label, the Vasopressin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2000-07.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock.

It also tracked 4 secondary outcomes, for example To compare these two categories of treatment on:, tonometric parameters and renal function.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; 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.