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

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04358016

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis, Liver Upper Gastrointestinal Bleeding	Drug: Terlipressin Drug: Somatostatin	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: terlipression

terlipression 1mg；once every 6 hours；5days

Drug: Terlipressin

Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding

Active Comparator: Control

Somatostatin，3mg， once every 12 hours; 5 days

Drug: Somatostatin

Somatostatin

Outcome Measures

Primary Outcome Measures

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

hemostasis rate [48 hours]
Fecal occult blood negative or hemoglobin stable after 48H treatment
incidence of hepatic encephalopathy [48 hours]
Increased blood ammonia or directional force and computational power decrease 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
The incidence of hyponatremia [48 hours]
Serum sodium levels below 130mmol/l

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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