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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Terlipressin group | Experimental | Continuous intravenous infusion of terlipressin 2-4 mg every 12 hours. |
|
| Somatostatin group | Active Comparator | Continuous intravenous infusion of somatostatin 3 mg every 12 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of AKI | The reversal of AKI is defined as clinical symptoms of AKI disappear and serum creatinine (SCr) levels decrease after treatment. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of AKI | The duration of AKI is defined as the time from occurrence to reversal of AKI. | 6 weeks |
| Recurrence of AKI | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xingshun Qi, MD | Contact | 18909881019 | xingshunqi@126.com | |
| Qianqian Li | Contact | 13940307473 | 1208594776@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xingshun Qi, MD | Department of Gastroenterology, General Hospital of Northern Theater Command | Principal Investigator |
| Qianqian Li | Department of Gastroenterology, General Hospital of Northern Theater Command | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32860184 | Result | 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. | |
| 1350562 |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| C000723528 | terlivaz |
| D013004 | Somatostatin |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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Parallel Assignment
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|
| 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. |
|
|
| 6 weeks |
| Kidney replacement therapy rate | Participants undergo dialysis or continuous kidney replacement therapy due to failure to recover renal function after treatment. | 6 weeks |
| Transjugular intrahepatic portosystemic shunt (TIPS) treatment rate | Participants undergo transjugular intrahepatic portosystemic shunt (TIPS) treatment. | 6 weeks |
| Liver and kidney transplantation treatment rate | Participants undergo liver and kidney transplantation treatment. | 6 weeks |
| 6-week mortality rate | The 6-week mortality rate is defined as the all-cause mortality rate over 6 weeks. | 6 weeks |
| 6-week rebleeding rate | The 6-week rebleeding rate is defined as the rebleeding rate within 6 weeks after successful AVB hemostasis. | 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. | 6 weeks |
| Rong Li | Department of Gastroenterology, General Hospital of Northern Theater Command | Principal Investigator |
| Result |
| 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. |
| 30508958 | Result | 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. |
| 38161497 | Result | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D010905 | Pituitary Hormone Release Inhibiting Hormones |
| D007028 | Hypothalamic Hormones |
| D010187 | Pancreatic Hormones |