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Terlipressin in Septic Shock in Cirrhosis
Plain-language guide to NCT00628160: phase 2, phase 3 randomized trial of Terlipressin, 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00628160
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2006-10
- Completion (planned or actual)
- 2012-12
- Participants
- 72 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Liver Cirrhosis; Septic Shock
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2, phase 3 trial, researchers set out to test Terlipressin.
Septic shock is a frequent and severe complication in cirrhosis.
It had two arms (groups): Terlipressin group (experimental) and Control group (active comparator).
Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion).
Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion).
The registry classes the interventions as drug.
More on the Plan
Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis.
Who Took Part
72 actual participants took part.
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: Age between 18 and 80 years;.
The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: more than 24 hours of evolution of the shock;; cardiac index \< 2,5 l/min;; advanced hepatocellular carcinoma (milan criteria);.
How the Study Was Run
Design: randomized, single-group and open-label.
Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.
Being open-label, the Terlipressin 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 2006-10 with completion listed for 2012-12.
It ran at 1 site in Spain.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Refractory shock, Variceal bleeding and Hepatorenal syndrome.
What This Means in Plain Language
Put simply, this is a phase 2, phase 3, randomized trial of Terlipressin in 72 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Terlipressin compound page, all human trials.
Our Notes on the Compound
Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.
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.