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

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

Study Overview

• Status: Completed
• Conditions: Hemodynamics, Liver, Terlipressin
• Intervention / Treatment: Drug: terlipressin; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Asyut Governorate
    • Assiut, Asyut Governorate, Egypt, 11111
      • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.; Other Names: glypressin
Placebo Comparator: CONTROL; 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).	Drug: normal saline; Patients receive 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.; Other Names: 0.9 Nacl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
portal pressure changes	portal pressure changes in mmHg	intraoperative period

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mostafa Samy, Assiut University

Publications and helpful links

General Publications

• Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: March 19, 2016
• First Submitted That Met QC Criteria: March 19, 2016
• First Posted (Estimate): March 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 17, 2017
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: ABC-123-DE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED