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Completed

NCT Number: NCT04358016

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

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

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Key information

Conditions

Cirrhosis, Liver Acute Kidney Injury Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fibrosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Kidney Diseases Liver Cirrhosis Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Upper Gastrointestinal Bleeding Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changhai hospital

Shanghai, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terlipressin

Drug

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

Somatostatin

Drug

Somatostatin

Primary outcomes

  1. 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

  1. hemostasis rate

    Time frame: 48 hours

    Fecal occult blood negative or hemoglobin stable after 48H treatment

  2. incidence of hepatic encephalopathy

    Time frame: 48 hours

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

  3. The incidence of spontaneous bacterial peritonitis;

    Time frame: 48 hours

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

  4. The incidence of hyponatremia

    Time frame: 48 hours

    Serum sodium levels below 130mmol/l

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 22, 2020
Registry last updated
Apr 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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