Back to results

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

Primary Purpose

Cirrhosis, Liver, Upper Gastrointestinal Bleeding

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Terlipressin

Somatostatin

About this trial

This is an interventional prevention trial for Cirrhosis, Liver focused on measuring liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Changhai hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

terlipression

Control

Arm Description

terlipression 1mg；once every 6 hours；5days

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

Outcomes

Primary Outcome Measures

incidence of acute kidney injure

serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline

Secondary Outcome Measures

hemostasis rate

Fecal occult blood negative or hemoglobin stable after 48H treatment

incidence of hepatic encephalopathy

Increased blood ammonia or directional force and computational power decrease after 48H treatment

The incidence of spontaneous bacterial peritonitis;

After 48H treatment, there is ascites and ascites has more than 20% nuclear cells

The incidence of hyponatremia

Serum sodium levels below 130mmol/l

Full Information

NCT ID

NCT04358016

First Posted

October 15, 2019

Last Updated

April 21, 2020

Sponsor

Changhai Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04358016

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

January 1, 2020 (Actual)

Study Completion Date

March 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis, Liver, Upper Gastrointestinal Bleeding

Keywords

liver cirrhosis, upper gastrointestinal bleeding, acute kidney injury, urinary IL-18

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

terlipression

Arm Type

Experimental

Arm Description

terlipression 1mg；once every 6 hours；5days

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Terlipressin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Somatostatin

Intervention Description

Somatostatin

Primary Outcome Measure Information:

Title

incidence of acute kidney injure

Description

serum creatinine level increased by 26.5umol/L during 48hours or increased 50% compared to baseline

Time Frame

48 hours

Secondary Outcome Measure Information:

Title

hemostasis rate

Description

Fecal occult blood negative or hemoglobin stable after 48H treatment

Time Frame

48 hours

Title

incidence of hepatic encephalopathy

Description

Increased blood ammonia or directional force and computational power decrease after 48H treatment

Time Frame

48 hours

Title

The incidence of spontaneous bacterial peritonitis;

Description

After 48H treatment, there is ascites and ascites has more than 20% nuclear cells

Time Frame

48 hours

Title

The incidence of hyponatremia

Description

Serum sodium levels below 130mmol/l

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xuesong Liang, Dr

Organizational Affiliation

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai hospital

City

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs