Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.

What Was Tested

This registered phase 4 trial tested Octreotide.

It had two arms (groups): norepinephrine (active comparator) and midodrine & octreotide (active comparator).

The registry classes the interventions as drug.

More on the Plan

Screening and eligibility criteria were verified upon admission to the ICU.

A diagnosis of AKI was established through comparing sCr value at time of ICU admission to that recorded in the patient's file.

Patients who meet all other diagnostic criteria of HRS-AKI provided by the previous definition \[2\] were enrolled in the study.

Qualified patients were subjected to baseline assessments after informed consent signature.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 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, parallel-group and single-blind study.

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

The Octreotide group and the comparison group ran side by side rather than switching.

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

Those kept unaware of assignments: participant.

It started in 2018-08-15 with completion listed for 2020-04-20.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: the proportion of patients achieved full response (time frame: within10 days).

It also tracked 5 secondary outcomes, for example the proportion of patients achieved partial response, Incidence of HRS reversal, incidence of HRS-AKI relapse, overall survival and adverse events experienced throughout the study period in both treatment groups.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Octreotide in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.