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Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney

Plain-language guide to NCT02059460: phase 4 randomized trial of Terlipressin, 25 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT02059460
Phase
phase 4
Status
completed
Start
2013-05
Completion (planned or actual)
2016-12
Participants
25 (actual)
Design
randomized, open label (everyone knows who gets what), prevention
Conditions studied
Acute Kidney Injury; Liver Transplantation; Terlipressin; NGAL
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Terlipressin.

To study the impact of intra and post-operative Terlipressin infusion on the occurrence of acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels.

It had two arms (groups): Terlipressin group (experimental) and Control group (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

They will be simply randomized with closed envelopes into two groups.

Terlipressin group and Control group.

A written informed consent will be taken from every patient.

Anesthetic Technique: All patients will be monitored by electrocardiography, noninvasive and invasive arterial blood pressure, pulse oximetry, capnography, fraction inspired oxygen concentration (FiO2).

Who Took Part

Enrollment: 25 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

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

It started in 2013-05 with completion listed for 2016-12.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Development of acute kidney injury (time frame: 5 days postoperatuvely).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Terlipressin in 25 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.