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

NCT ID: NCT04358016

Last Updated: 2020-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-03-01

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.

Conditions

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Cirrhosis, Liver Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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terlipression

terlipression 1mg;once every 6 hours;5days

Group Type EXPERIMENTAL

Terlipressin

Intervention Type DRUG

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

Control

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

Group Type ACTIVE_COMPARATOR

Somatostatin

Intervention Type DRUG

Somatostatin

Interventions

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Terlipressin

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

Intervention Type DRUG

Somatostatin

Somatostatin

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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LiangXS

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuesong Liang, Dr

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Changhai hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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LDWJPMF-102-1700

Identifier Type: -

Identifier Source: org_study_id

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