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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Blood Loss; Terlipressin

Treatments: Drug: Terlipressin; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03572088

ABC-223-DE

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Terlipresssin

Active Comparator group

Description:

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.

Treatment:

Drug: Terlipressin

Control

Placebo Comparator group

Description:

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)

Treatment:

Drug: normal saline