Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Phase 2

Completed

• Conditions: Hemodynamics, Liver, Terlipressin
• Interventions: Drug: normal saline; Drug: terlipressin

• Registration Number: NCT02718599
• Lead Sponsor: Assiut University

Brief Summary

To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-19
• Study First Submitted QC: 2016-03-19
• Study First Posted: 2016-03-24
• Study Start: 2016-04
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-12-17
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age > 18 years.
• Any gender.
• ASA (American Society of Anesthesiologists) Classification( Class I-II)
• Patients undergoing major elective hepatobiliary surgery.

Exclusion Criteria

• Preoperative renal failure (GFR < 50 ml/min).
• Severe liver dysfunction (Child- turcotte -Pugh grade C).
• Hyponatremia (<132 mmol/l).
• Severe aortic regurgitation, severe mitral regurgitation, heart failure.
• Symptomatic coronary heart disease.
• Bradycardic arrhythmia (heart rate < 60/min).
• Peripheral artery occlusive disease (clinical stadium II-IV).
• Uncontrolled arterial hypertension (Blood pressure >160/100 mmHg despite intensive treatment).
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	normal saline	Patients receive the same volume of 0.9% saline in place of terlipressin for the same duration(50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours).
Terlipressin	terlipressin	Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.

Primary Outcome Measures

Name	Time	Method
portal pressure changes	intraoperative period	portal pressure changes in mmHg

Secondary Outcome Measures

Name	Time	Method
Renal impairment	for 3 days in the postoperative period	Number of patients with renal impairment \[defined as at least a doubling of serum creatinine or oliguria (\<500 mL/24 hours)\].
Effect on systemic vascular resistance	intraoperative period	•Effect on systemic vascular resistance in dyne.s/cm5
Blood units transfused	intraoperative period	Number of packed RBCs (red blood cells) units transfused

Trial Locations

Locations (1)

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