Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding

Phase 4

Completed

• Conditions: Cirrhosis, Liver; Upper Gastrointestinal Bleeding
• Interventions: Drug: Terlipressin; Drug: Somatostatin

• Registration Number: NCT04358016
• Lead Sponsor: Changhai Hospital

Brief Summary

The investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point.

Detailed Description

54 cirrhotic patients with uppre-gastrointestinal bleeding were entrolled and were distributed into terlipressin group and control group at 1:1 rate. Patients in Terlipressin group received 1mg/6h of terlipressin intravenously for 5 days, and patients in control group recerved 1mg/12h of Somatostatin intravenously for 5 days.

At enrollment, 24h,48h,72,and 1week, the renal function index level( serum creatinine,urine biochemistry and Urinary tubule injury index etc) were tested.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2019-10-15
• Status Verified: 2019-11
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-01
• Study First Submitted QC: 2020-04-21
• Last Update Submitted: 2020-04-21
• Study First Posted: 2020-04-22
• Last Update Posted: 2020-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Diagnosied as cirrhosis with upper gastrointestinal bleeding 18≤age≤70 Varicose vein rupture occurred within 24 hours, Without drug, endoscopy or interventional therapy Can read, understand and sign informed consent

Exclusion Criteria

• Pregnant women, lactating women; Serious cardiovascular disease: history of acute cardiac infarction, heart block, heart failure, arterial hypertension(（SBP>170mmHg and/ or DBP>100mmHg） Occlusive lower extremity venous disease Asthma, chronic obstructive pulmonary disease Have serious or unable to control other organ diseases; Cerebrovascular disease; Age ≥70 years old Known to be allergic to therapeutic drugs Chronic kidney disease Weight ≤40kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
terlipression	Terlipressin	terlipression 1mg；once every 6 hours；5days
Control	Somatostatin	Somatostatin，3mg， once every 12 hours; 5 days

Primary Outcome Measures

Name	Time	Method
incidence of acute kidney injure	48 hours	serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline

Secondary Outcome Measures

Name	Time	Method
The incidence of hyponatremia	48 hours	Serum sodium levels below 130mmol/l
hemostasis rate	48 hours	Fecal occult blood negative or hemoglobin stable after 48H treatment
The incidence of spontaneous bacterial peritonitis;	48 hours	After 48H treatment, there is ascites and ascites has more than 20% nuclear cells
incidence of hepatic encephalopathy	48 hours	Increased blood ammonia or directional force and computational power decrease after 48H treatment

Trial Locations

Locations (1)

Changhai hospital; 🇨🇳 Shanghai, China