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

Phase 2CompletedNCT03572088

Assiut University40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Terlipressin Blood Loss

Interventions

TerlipressinDRUG

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.)

normal salineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Intraoperative blood loss

Amount of intraoperative blood loss in ml

Time frame: intaoperative periods

Secondary Outcomes

Patients needing blood transfusion

Number of patients needing blood transfusion

Time frame: intaoperative periods

Red blood cell units transfused

The number of red blood cell units transfused

Time frame: intaoperative periods

portal pressure changes

portal pressure changes in mmHg

Time frame: intaoperative periods

ICU stay

ICU stay in days

Time frame: postoperative periods

Data from ClinicalTrials.gov

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