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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04358016
• Other study ID #: LDWJPMF-102-1700
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2018
• Est. completion date: March 1, 2020

Study information

• Verified date: November 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cirrhosis, Liver
• Fibrosis
• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhosis
• Upper Gastrointestinal Bleeding

Intervention

Drug:
• Terlipressin
Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding
• Somatostatin
Somatostatin

Locations

Country	Name	City	State
China	Changhai hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of acute kidney injure	serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline	48 hours
Secondary	hemostasis rate	Fecal occult blood negative or hemoglobin stable after 48H treatment	48 hours
Secondary	incidence of hepatic encephalopathy	Increased blood ammonia or directional force and computational power decrease after 48H treatment	48 hours
Secondary	The incidence of spontaneous bacterial peritonitis;	After 48H treatment, there is ascites and ascites has more than 20% nuclear cells	48 hours
Secondary	The incidence of hyponatremia	Serum sodium levels below 130mmol/l	48 hours