Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs

The present study aims to look at the effect of terlipressin infusion on blood loss and blood transfusion needs during Whipple procedure

Study Overview

• Status: Completed
• Conditions: Blood Loss; Terlipressin
• Intervention / Treatment: Drug: Terlipressin; Drug: normal saline

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• All patients older than 18 years of age,
• ASA classification class I and II,
• Patients assigned for Whipple procedure.

Exclusion Criteria:

• Preoperative renal failure,
• Severe liver dysfunction (Child-Turcotte-Pugh grade C),
• Hyponatremia (Na+ <132mmol/l),
• Severe valvular heart disease,
• 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 >160/100mmHg 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: Terlipresssin; Terlipressin was started at the beginning of surgery, just after exposure of the portal vein and getting a basal portal pressure reading, as an initial bolus dose of 1 mg over 30 minutes (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 is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was 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 received the same volume of normal saline 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 received 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
Intraoperative blood loss	Amount of intraoperative blood loss in ml	intaoperative periods

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients needing blood transfusion	Number of patients needing blood transfusion	intaoperative periods
Red blood cell units transfused	The number of red blood cell units transfused	intaoperative periods
portal pressure changes	portal pressure changes in mmHg	intaoperative periods
ICU stay	ICU stay in days	postoperative periods

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Assiut University hospital Egypt, Egypt, Assiut University

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: June 17, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (Actual): June 28, 2018

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Antihypertensive Agents; Vasoconstrictor Agents; Terlipressin
• Other Study ID Numbers: ABC-223-DE

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No