NCT04358016

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 22, 2020

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

October 15, 2019

Last Update Submit

April 21, 2020

Conditions

Cirrhosis, LiverUpper Gastrointestinal Bleeding

Keywords

liver cirrhosisupper gastrointestinal bleedingacute kidney injuryurinary IL-18

Outcome Measures

Primary Outcomes (1)

  • incidence of acute kidney injure

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

    48 hours

Secondary Outcomes (4)

  • hemostasis rate

    48 hours

  • incidence of hepatic encephalopathy

    48 hours

  • The incidence of spontaneous bacterial peritonitis;

    48 hours

  • The incidence of hyponatremia

    48 hours

Study Arms (2)

terlipression

EXPERIMENTAL

terlipression 1mg；once every 6 hours；5days

Drug: Terlipressin

Control

ACTIVE COMPARATOR

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

Drug: Somatostatin

Interventions

TerlipressinDRUG

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

terlipression
SomatostatinDRUG

Somatostatin

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Liver CirrhosisGastrointestinal HemorrhageAcute Kidney Injury

Interventions

TerlipressinSomatostatin

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesHemorrhageRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsPituitary Hormone Release Inhibiting HormonesHypothalamic HormonesPancreatic Hormones

Study Officials

  • Xuesong Liang, Dr

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2019

First Posted

April 22, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

April 22, 2020

Record last verified: 2019-11

Locations

CN(1)