DRUG
Terlipressin
Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding
Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding
Status
Completed
Phase
Phase 4
Enrollment
54
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The investigators studied the renal function index level in terlipressin treated cirrhotic patients with upper-gastrointestinal bleeding at different time point.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Somatostatin
Somatostatin
Timeline
From registration to results.
First posted
Apr 22, 2020
Study start
Jan 1, 2018
Primary completion
Jan 1, 2020
Study completion
Mar 1, 2020
Results posted
Not reported
Registry updated
Apr 22, 2020
Outcomes
What the study measures.
Primary outcomes
incidence of acute kidney injure
Time frame · 48 hours
serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline
Secondary outcomes
hemostasis rate
Time frame · 48 hours
Fecal occult blood negative or hemoglobin stable after 48H treatment
incidence of hepatic encephalopathy
Time frame · 48 hours
Increased blood ammonia or directional force and computational power decrease after 48H treatment
The incidence of spontaneous bacterial peritonitis;
Time frame · 48 hours
After 48H treatment, there is ascites and ascites has more than 20% nuclear cells
The incidence of hyponatremia
Time frame · 48 hours
Serum sodium levels below 130mmol/l
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Changhai hospital
Shanghai, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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