Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding

What Was Tested

This registered phase 4 trial tested Somatostatin and Terlipressin.

It had two arms (groups): terlipression (experimental) and Control (active comparator).

The registry classes the interventions as drug.

More on the Plan

54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were distributed into terlipressin group and control group at 1:1 rate.

At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine biochemistry and Urinary tubule injury index etc) were tested.

Who Took Part

Enrollment: 54 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Diagnosied as cirrhosis with upper gastrointestinal bleeding 18≤age≤70 Varicose vein rupture occurred within 24 hours, Without drug, endoscopy or interventional therapy Can read, understand and sign informed consent.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Somatostatin study did not mask who received what.

It started in 2018-01-01 with completion listed for 2020-01-01.

It ran at 1 site in China.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): incidence of acute kidney injure (time frame: 48 hours).

It also tracked 4 secondary outcomes, for example hemostasis rate, incidence of hepatic encephalopathy, The incidence of spontaneous bacterial peritonitis; and The incidence of hyponatremia.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Somatostatin and Terlipressin in 54 people.

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

More context: the Somatostatin compound page and the Terlipressin compound page, all human trials.