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NCT Number: NCT07252401

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury

Acute gastrointestinal bleeding (AGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Existing evidence suggests that both terlipressin and somatostatin can be used to control AVB in cirrhotic patients, but terlipressin may be the first-line treatment for cirrhotic patients with AGIB complicated by acute kidney injury (AKI). Herein, a multicenter randomized controlled trial (RCT) has been designed to compare the efficacy of terlipressin and somatostatin in the treatment of cirrhotic patients with AGIB complicated by AKI.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Overall, 64 cirrhotic patients with a diagnosis of AGIB and AKI will be enrolled. They will be stratified according to the severity of AKI, and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary endpoint is reversal of AKI after treatment on 5 days. Secondary endpoints include duration of AKI, recurrence of AKI, rates of renal replacement therapy, transjugular intrahepatic portosystemic shunt (TIPS) treatment, liver, and kidney transplantation, 6-week mortality, 6-week rebleeding rate, and incidence of adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients have a definite diagnosis of live cirrhosis and AKI;
  • patients present with AGIB at admission;
  • patients' age 18-70 years old;
  • patients or relatives can sign the informed consent form.

Exclusion criteria

  • patients have hepatorenal syndrome- acute renal injury (HRS-AKI);
  • patients have structural kidney injury;
  • patients have chronic kidney disease;
  • patients received terlipressin or somatostatin therapy within 48 hours before enrollment;
  • patients received kidney replacement therapy before enrollment;
  • patients have a history of liver transplantation or TIPS;
  • patients have acute liver failure or acute-on-chronic liver failure;
  • patients have hepatic or renal malignant tumor;
  • patients have severe diseases of the heart, lungs, and brain;
  • patients have contraindications for experimental drugs;
  • patients are in pregnancy or lactation;
  • patients participated in other clinical studies within 3 months before enrollment;
  • patients have other conditions that investigators deem unsuitable for enrollment in the study.

Treatment and study plan

2-4 mg of terlipressin

Drug

Participants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.

Other names: Terlivaz

3 mg of somatostatin

Drug

Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.

Other names: Stilamin

Primary outcomes

  1. Reversal of AKI

    Time frame: 5 days

    The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.

Secondary outcomes

  1. Duration of AKI

    Time frame: 6 weeks

    The duration of AKI is defined as the time from occurrence to reversal of AKI.

  2. Recurrence of AKI

    Time frame: 6 weeks

    Clinical symptoms related to AKI recur and SCr levels increase after the reserval of AKI. The diagnosis of AKI should meet any of the following conditions: an increase in SCr level of ≥0.3 mg/dl (26.5 μmol/L) within 48 hours; or an increase in SCr level to ≥1.5 times the baseline value within 7 days; or urine output <0.5 ml/kg per hour for a continuous 6 hours.

  3. Kidney replacement therapy rate

    Time frame: 6 weeks

    Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.

  4. Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate

    Time frame: 6 weeks

    Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.

  5. Liver and kidney transplantation treatment rate

    Time frame: 6 weeks

    Participants undergo liver and kidney transplantation treatment.

  6. 6-week mortality rate

    Time frame: 6 weeks

    The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.

  7. 6-week rebleeding rate

    Time frame: 6 weeks

    The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.

  8. Adverse events

    Time frame: 6 weeks

    Adverse events will be monitored, including nausea, abdominal pain, diarrhea, arrhythmia, dyspnea, and hyponatremia that may be caused by terlipressin, as well as nausea, abdominal pain, diarrhea, hypoglycemia, and allergies that may be caused by somatostatin.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianqian Li

CONTACT

[email protected]

13940307473

Xingshun Qi, MD

CONTACT

[email protected]

18909881019

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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