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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Hepatectomy, Surgical Blood Loss, Terlipressin

Treatments: Drug: normal saline; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT02588716

Terlipressin

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

84 participants in 2 patient groups, including a placebo group

Terlipressin

Active Comparator group

Description:

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(1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

Treatment:

Drug: Terlipressin

Control

Placebo Comparator group

Description:

same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.

Treatment:

Drug: normal saline