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

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

Detailed Description
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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.

Official Title
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The Protection of Telipression on Developing of Acute Kidney Injury in Cirrhotic Patients With Upper-gastroentestinal Bleeding

Conditions
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Cirrhosis, Liver, Upper Gastrointestinal Bleeding

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Somatostatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: terlipression<br>terlipression 1mg；once every 6 hours；5days | Drug: Terlipressin<br>* Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding<br>|
| Active Comparator: Control<br>Somatostatin，3mg， once every 12 hours; 5 days | Drug: Somatostatin<br>* Somatostatin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of acute kidney injure | serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline | 48 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18