Liver CirrhosisNCT07252401
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction
A study testing 2-4 mg of terlipressin and 3 mg of somatostatin in people with Liver Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial summary
Acute upper gastrointestinal bleeding (AUGIB) is a common complication in the decompensated stage of liver cirrhosis, of which approximately 70% is acute variceal bleeding (AVB) caused by portal hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- 2-4 mg of terlipressin and 3 mg of somatostatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2026to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients have a definite diagnosis of live cirrhosis and AVB;
- patients present with renal dysfunction at admission;
- patients' age 18-70 years old;
- patients or relatives can sign the informed consent form.
Who cannot join
- patients have non-variceal upper gastrointestinal bleeding;
- patients have hepatorenal syndrome- acute renal injury (HRS-AKI);
- patients have structural kidney injury;
- patients have chronic kidney disease;
- patients received kidney replacement therapy before enrollment;
- patients have a history of liver transplantation or TIPS;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning
Xingshun Qi, MD, 18909881019, xingshunqi@126.com
Qianqian Li, 13940307473, 1208594776@qq.com
About this study
Official title: Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction: A Multicenter Randomized Controlled Trial
Acute upper gastrointestinal bleeding (AUGIB) 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 AVB complicated by renal dysfunction (RD). 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 AVB complicated by RD.
Read the detailed description
Overall, 64 cirrhotic patients with a diagnosis of AVB and RD will be enrolled. Renal dysfunction is defined as serum creatinine (SCr) level >1.5 mg/dl at admission. They will be stratified according to the severity of liver dysfunction (i.e., Child-Pugh class A, B, and C) and degree of SCr level elevation [i.e., 1.5-2mg/dl (133-177 μmol/L), 2-3 mg/dl (177-265 μmol/L), and ≥3 mg/dl (265 μmol/L)], and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary study endpoint is renal function recovery after 5-day treatment. Secondary endpoints include incidence of AKI within 7 days, 5-day failure to control bleeding, requirement of renal replacement therapy, TIPS, liver transplantation, and kidney transplantation within 6 weeks, 6-week mortality, 6-week rebleeding, and incidence of adverse events within 6 weeks.
- Conditions
- Liver Cirrhosis
- Being tested
- 2-4 mg of terlipressin, 3 mg of somatostatin
- Keywords
- terlipressin, somatostatin, liver cirrhosis, acute upper gastrointestinal bleeding, renal dysfunction, acute kidney injury, acute variceal bleeding
- Medical subject headings
- Liver Cirrhosis, Renal Insufficiency, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-4 mg of terlipressinDrug
Also called Terlivaz
Participants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
3 mg of somatostatinDrug
Also called Stilamin
Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin group | Experimental | Continuous intravenous infusion of terlipressin 2-4 mg every 12 hours. Receives: Drug: 2-4 mg of terlipressin |
| Somatostatin group | Active comparator | Continuous intravenous infusion of somatostatin 3 mg every 12 hours. Receives: Drug: 3 mg of somatostatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal function recovery
The renal function recovery is defined as SCr level ≤ 1.5 mg/dl (133 μmol/L) in two consecutive measurements with an interval of at least 2 hours between them.
Measured: 6 weeks
Secondary outcomes (8)
Incidence of AKI within 7 days
Clinical symptoms related to AKI occur and SCr levels increase after the treatment. The diagnosis of AKI should meet any one of the following conditions: 1) an increase in SCr level of ≥ 0.3 mg/dl (26.5 μmol/L) within 48 hours; 2) an increase in SCr level to ≥ 1.5 times the baseline value within 7 days; 3) a urine output of < 0.5 ml/kg per hour for a continuous 6 hours.
Measured: 7 days
5-day failure to control bleeding
The 5-day failure to control bleeding is defined as failure to achieve effective control of AVB or occurrence of rebleeding within 5 days after treatment.
Measured: 5 days
Kidney replacement therapy rate
Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.
Measured: 6 weeks
Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
Measured: 6 weeks
Liver and kidney transplantation treatment rate
Participants undergo liver and kidney transplantation treatment.
Measured: 6 weeks
6-week mortality rate
The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.
Measured: 6 weeks
6-week rebleeding rate
The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.
Measured: 6 weeks
Adverse events
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. The incidence of adverse events is defined as rate of adverse reactions secondary to terlipressin or somatostatin, endoscopic therapy or interventional procedures during study periods.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start25 Sep 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, MD, Principal investigator, Department of Gastroenterology, General Hospital of Northern Theater CommandQianqian Li, Principal investigator, Department of Gastroenterology, General Hospital of Northern Theater CommandRong Li, Principal investigator, Department of Gastroenterology, General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252401
- Sponsor's protocol ID
- TERLI-AVB-RD
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32860184Walker 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.
PubMed 1350562Zhou 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.
PubMed 30508958Xu 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.
PubMed 38161497
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Variceal Bleeding and Renal Dysfunction: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07252401
- Acronym / sponsor ID
- TERLI-AVB-RD
- Conditions
- Liver Cirrhosis
- Keywords
- terlipressin, somatostatin, liver cirrhosis, acute upper gastrointestinal bleeding, renal dysfunction, acute kidney injury, acute variceal bleeding
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute upper gastrointestinal bleeding (AUGIB) 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 AVB complicated by renal dysfunction (RD). 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 AVB complicated by RD.
Detailed description
Overall, 64 cirrhotic patients with a diagnosis of AVB and RD will be enrolled. Renal dysfunction is defined as serum creatinine (SCr) level >1.5 mg/dl at admission. They will be stratified according to the severity of liver dysfunction (i.e., Child-Pugh class A, B, and C) and degree of SCr level elevation [i.e., 1.5-2mg/dl (133-177 μmol/L), 2-3 mg/dl (177-265 μmol/L), and ≥3 mg/dl (265 μmol/L)], and then randomly assigned to terlipressin group and somatostatin group at a ratio of 1:1. The primary study endpoint is renal function recovery after 5-day treatment. Secondary endpoints include incidence of AKI within 7 days, 5-day failure to control bleeding, requirement of renal replacement therapy, TIPS, liver transplantation, and kidney transplantation within 6 weeks, 6-week mortality, 6-week rebleeding, and incidence of adverse events within 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Terlipressin group | Experimental | Drug: 2-4 mg of terlipressinContinuous intravenous infusion of terlipressin 2-4 mg every 12 hours. |
| Somatostatin group | Active comparator | Drug: 3 mg of somatostatinContinuous intravenous infusion of somatostatin 3 mg every 12 hours. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients have a definite diagnosis of live cirrhosis and AVB;
- patients present with renal dysfunction at admission;
- patients' age 18-70 years old;
- patients or relatives can sign the informed consent form.
Key exclusion criteria (13 listed)
- patients have non-variceal upper gastrointestinal bleeding;
- patients have hepatorenal syndrome- acute renal injury (HRS-AKI);
- patients have structural kidney injury;
- patients have chronic kidney disease;
- patients received kidney replacement therapy before enrollment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-4 mg of terlipressinAlso: TerlivazParticipants receive 2-4 mg of terlipressin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days. | Drug | Terlipressin group |
| 3 mg of somatostatinAlso: StilaminParticipants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days. | Drug | Somatostatin group |
Primary outcome
Renal function recovery
Time frame: 6 weeks
The renal function recovery is defined as SCr level ≤ 1.5 mg/dl (133 μmol/L) in two consecutive measurements with an interval of at least 2 hours between them.
8 secondary outcomes
Incidence of AKI within 7 days
Time frame: 7 days
5-day failure to control bleeding
Time frame: 5 days
Kidney replacement therapy rate
Time frame: 6 weeks
Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate
Time frame: 6 weeks
Liver and kidney transplantation treatment rate
Time frame: 6 weeks
6-week mortality rate
Time frame: 6 weeks
6-week rebleeding rate
Time frame: 6 weeks
Adverse events
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Results publication: PubMed 32860184Xu 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.
- Results publication: PubMed 1350562Walker 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.
- Results publication: PubMed 30508958Zhou 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.
- Results publication: PubMed 38161497Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingshun Qi, MD principal investigator
Department of Gastroenterology, General Hospital of Northern Theater Command
Qianqian Li principal investigator
Department of Gastroenterology, General Hospital of Northern Theater Command
Rong Li principal investigator
Department of Gastroenterology, General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-4 mg of terlipressin and 3 mg of somatostatin in people with Liver Cirrhosis, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi, MD (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal function recovery (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252401, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.