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Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage

G

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status

Completed

Conditions

Cirrhosis, Liver
Variceal Hemorrhage
Kidney Injury

Treatments

Drug: Octreotide
Drug: Somatostatin
Drug: Terlipressin

Study type

Observational

Funder types

Other

Identifiers

NCT03846180
XHNKKY-VASO 2.0

Details and patient eligibility

About

Terlipressin and somatostatin/octreotide are the first-line choices for the treatment of acute variceal bleeding in liver cirrhosis. Acute kidney injury can develop in patients presenting with acute variceal bleeding. On the other hand, evidence suggests that terlipressin can reverse hepatorenal syndrome. It has been hypothesized that terlipressin can protect the renal function in cirrhotic patients with acute variceal bleeding, except for control of bleeding.

Enrollment

1,682 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Cirrhotic patients who were admitted between January 2010 and December 2018.
  2. A diagnosis of acute gastrointestinal bleeding.
  3. Patients who received terlipressin or somatostatin/octreotide.
  4. Age or sex was not limited.
  5. Use of endoscopy was not limited.
  6. Comorbidity was not limited.
  7. Malignancy was not limited.

Exclusion criteria

  1. Renal parenchymal diseases.
  2. Absence of baseline serum creatinine.
  3. Absence of serum creatinine 3-5 days after terlipressin or somatostatin/octreotide.
  4. Duration of terlipressin or somatostatin/octreotide was less 3 days.
  5. Patients who underwent transjugular intrahepatic portosystemic shunt.
  6. Patients who underwent surgical shunt, splenectomy with or without devascularization, or liver transplantation.

Trial design

1,682 participants in 2 patient groups

Terlipressin group
Description:
Cirrhotic patients with acute gastrointestinal bleeding received terlipressin with or without somatostatin/octreotide.
Treatment:
Drug: Terlipressin
Somatostatin/Octreotide group
Description:
Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.
Treatment:
Drug: Somatostatin
Drug: Octreotide

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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