Acute Kidney Injury, Ascites Hepatic, Liver Failure, Terlipressin Adverse Reaction
Conditions
Keywords
hepatectomy, terlipressin, liver failure, acute kidney injury
Brief summary
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension.
Detailed description
Portal vein hypertension is associated with post-hepatectomy liver failure in patients with liver cirrhosis. Our previous study found that bolus injection of 1 mg terlipressin immediately after hepatectomy decreased portal vein pressure, and post-operative continuous use of terlipressin decreased the amount of abdominal drain. In this multicenter randomized controlled study, we aim to evaluate the effects of terlipressin in the patients who underwent liver resection complicated by portal vein hypertension. The primary outcome is the total abdominal drain on postoperative day (POD) 1 to 3. The secondary outcomes are: (1) the incidence of post-hepatectomy liver failure; (2) post-operative acute kidney injury; (3) the side effects of terlipressin.
Interventions
DRUGTerlipressin plus standard care
All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.
OTHERStandard care
All the participants received routine care after surgery only.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects signed informed consent. * An open liver resection is planned. * Hepatitis B virus infection background. * Pre-operative liver function is Child-Pugh A. * Subjects with clinical significance portal vein hypertension or the liver stiffness \> 12 kPa before surgery. * Portal vein pressure \> 12 mmHg at 5 min after liver resection.
Exclusion criteria
* Age \< 18 y or \> 75 y. * Subjects received anti-cancer therapy within 3 months before surgery, or with a history of open or laparoscopic surgery. * Portal vein tumor thrombus was confirmed by preoperative imaging study. * Obstruction of biliary tract. * Pre-operative ALT or AST \> 2×ULN. * A history of myocardial infarction or chronic kidney disease. * Severe arrhythmia. * Intraoperative portal vein pressure could not be measured technically. * Any other contraindications of the terlipressin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total abdominal drainage | From post-operative day 1 to day 4. | from postoperative day 1 through day 3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of post-hepatectomy liver failure | From post-operative day 1 to day 30. | based on the criteria of ISGLS 2011. |
| The incidence of acute kidney injury | From post-operative day 1 to day 30. | defined as an absolute increase in serum creatinine (Cr) ≥ 0.3 mg/dl (26.5 μmol/L) and/or ≥ 50% from baseline |
| The side effects of terlipressin | From post-operative day 1 to day 30. | the incidences of abdominal pain, diarrhea, headache, hyponatremia, and hypertension |
Countries
China
Contacts
Primary ContactXiao-Dong Zhu, MD&PhD
Outcome results
None listed