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

N

Naval Military Medical University

Status and phase

Completed
Phase 4

Conditions

Cirrhosis, Liver
Upper Gastrointestinal Bleeding

Treatments

Drug: Somatostatin
Drug: Terlipressin

Study type

Interventional

Funder types

Other

Identifiers

NCT04358016
LDWJPMF-102-1700

Details and patient eligibility

About

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

Full 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.

Enrollment

54 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54 participants in 2 patient groups

terlipression
Experimental group
Description:
terlipression 1mg;once every 6 hours;5days
Treatment:
Drug: Terlipressin
Control
Active Comparator group
Description:
Somatostatin,3mg, once every 12 hours; 5 days
Treatment:
Drug: Somatostatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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