Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
Location contact
Qianqian Li
CONTACT
Xingshun Qi, MD
CONTACT
NCT Number: NCT07252401
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Shenyang, Liaoning, China
Qianqian Li
CONTACT
Xingshun Qi, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Participants receive 3 mg of somatostatin by continuous intravenous infusion every 12 hours, with a maximum treatment course of 5 days.
Other names: Stilamin
Time frame: 5 days
The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment.
Time frame: 6 weeks
The duration of AKI is defined as the time from occurrence to reversal 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.
Time frame: 6 weeks
Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment.
Time frame: 6 weeks
Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment.
Time frame: 6 weeks
Participants undergo liver and kidney transplantation treatment.
Time frame: 6 weeks
The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks.
Time frame: 6 weeks
The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis.
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.
Contact information is provided by the study sponsor or research team.
Qianqian Li
CONTACT
Xingshun Qi, MD
CONTACT
General Hospital of Shenyang Military Region
Other
Terlipressin vs. Somatostatin in Cirrhotic Patients With Acute Gastrointestinal Bleeding and Acute Kidney Injury: A Multicenter Randomized Controlled Trial
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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