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Treatment of Type-1 Hepatorenal Syndrome Associated With Sepsis
Plain-language guide to NCT01932151: not phased interventional trial of Terlipressin, 18 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01932151
- Phase
- not phased
- Status
- completed
- Start
- 2012-12
- Completion (planned or actual)
- 2013-07
- Participants
- 18 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Hepatorenal Syndrome
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around Terlipressin.
Type-1 HRS is often precipitated by a bacterial infection, though it may occur spontaneously.
It had 1 arm (groups): Terlipressin and albumin (other).
The registry classes the interventions as drug.
Who Took Part
The registry lists 18 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age between 18 and 85 years. Presence of sepsis, as defined by active infection, and signs of Systemic Inflammatory Response Syndrome. Occurrence of type-1 HRS during the infection, as defined by standard diagnostic criteria.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: hepatocellular carcinoma outside the milan criteria; any severe extrahepatic condition, including cardiovascular, neurological, and organic kidney diseases; septic or hypovolemic shock.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2012-12 with completion listed for 2013-07.
It ran at 1 site in Spain.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change in serum creatinine values (time frame: baseline and 14 days).
It also tracked 4 secondary outcomes, for example changes in glomerular filtration rate, Changes in arterial pressure, changes in plasma renin activity and changes in norepinephrine concentration.
What This Means in Plain Language
Put simply, this is a not phased trial of Terlipressin in 18 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 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.