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Discontinuation Order of Vasopressors in Septic Shock

Plain-language guide to NCT01493102: not phased randomized trial of Vasopressin, 78 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01493102
Phase
not phased
Status
terminated early
Start
2011-12
Completion (planned or actual)
2013-12
Participants
78 (actual)
Design
randomized, single-blind, supportive_care
Conditions studied
Septic Shock
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Vasopressin.

The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

It had two arms (groups): Vasopressin (active comparator) and Norepinephrine (active comparator).

The registry classes the interventions as drug.

More on the Plan

There are little data regarding the discontinuation of vasopressors in patients with septic shock.

Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Who Took Part

The registry lists 78 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Patients 20 years of age or older. Patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients who expired or had care withdrawn while receiving norepinephrine and vasopressin; patients being transferred into the icu from an outside facility or the operating room; patients who are suspected to have vasopressin deficiency (eg. hpa axis dysfunction, empty sella).

How the Study Was Run

Design: randomized, parallel-group and single-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.

Only one side, usually the participants, was kept unaware of whether Vasopressin was given.

Those kept unaware of assignments: participant.

It started in 2011-12 with completion listed for 2013-12.

It ran at 1 site in South Korea.

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Incidence of hypotension.

It also tracked 5 secondary outcomes, for example Time of hypotension, Vasopressor free day, 28-day mortality, ICU mortality and In-hospital mortality.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 78 people.

It ended early (terminated); 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.