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

Phase 2

Completed

• Conditions: Terlipressin; Blood Loss
• Interventions: Drug: normal saline; Drug: Terlipressin

• Registration Number: NCT03572088
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Study First Submitted: 2018-06-17
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-06-28
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	normal saline	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)
Terlipresssin	Terlipressin	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.

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	intaoperative periods	Amount of intraoperative blood loss in ml

Secondary Outcome Measures

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