Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Phase 2

Completed

• Conditions: Hepatectomy, Surgical Blood Loss, Terlipressin
• Interventions: Drug: normal saline; Drug: Terlipressin

• Registration Number: NCT02588716
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the effects of Terlipressin infusion on blood loss \& transfusion requirements in cirrhotic patients undergoing major liver resections.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-07
• Study Start: 2015-09
• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Last Update Submitted: 2017-12-23
• Last Update Posted: 2017-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• All patients older than 18 years of age, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

Exclusion Criteria

• Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	normal saline	same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.
Terlipressin	Terlipressin	Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

Primary Outcome Measures

Name	Time	Method
blood loss	intraoperative period	blood loss in ml

Secondary Outcome Measures

Name	Time	Method
blood units transfused	intraoperative period	number of packed RBCs units transfused
lactate level	at start and end of resection	lactate level in blood gas sample in mmol/L

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Asyut Governorate, Egypt