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NCT07252401·Not applicable·INTERVENTIONAL

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

VasopressinTerlipressinOtherNot yet recruiting

Status

Not yet recruiting

Phase

Not applicable

Enrollment

64

Locations

1

Results

Not posted

Publications

4

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DRUG

2-4 mg of terlipressin

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

DRUG

3 mg of somatostatin

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

Timeline

From registration to results.

  1. First posted

    Nov 26, 2025

  2. Study start

    Dec 25, 2025

  3. Primary completion

    Mar 31, 2028

  4. Study completion

    Mar 31, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Nov 26, 2025

Outcomes

What the study measures.

Primary outcomes

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

Duration of AKI

Time frame · 6 weeks

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

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.

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.

Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate

Time frame · 6 weeks

Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.

Liver and kidney transplantation treatment rate

Time frame · 6 weeks

Participants undergo liver and kidney transplantation treatment.

6-week mortality rate

Time frame · 6 weeks

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

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Publications

Results and literature.

PMID 32860184 ↗Xu X, Liu B, Lin S, Li B, Wu Y, Li Y, Zhu Q, Yang Y, Tang S, Meng F, Chen Y, Yuan S, Shao L, Bernardi M, Yoshida EM, Qi X. Terlipressin May Decrease In-Hospital Mortality of Cirrhotic Patients with Acute Gastrointestinal Bleeding and Renal Dysfunction: A Retrospective Multicenter Observational Study. Adv Ther. 2020 Oct;37(10):4396-4413. doi: 10.1007/s12325-020-01466-z. Epub 2020 Aug 28.PMID 1350562 ↗Walker S, Kreichgauer HP, Bode JC. Terlipressin vs. somatostatin in bleeding esophageal varices: a controlled, double-blind study. Hepatology. 1992 Jun;15(6):1023-30. doi: 10.1002/hep.1840150609.PMID 30508958 ↗Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.PMID 38161497 ↗Xu X, Tang C, Linghu E, Ding H; Chinese Society of Hepatology, Chinese Medical Association; Chinese Society of Gastroenterology, Chinese Medical Association; Chinese Society of Digestive Endoscopy, Chinese Medical Association. Guidelines for the Management of Esophagogastric Variceal Bleeding in Cirrhotic Portal Hypertension. J Clin Transl Hepatol. 2023 Dec 28;11(7):1565-1579. doi: 10.14218/JCTH.2023.00061. Epub 2023 Oct 17.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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