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

NCT ID: NCT03572088

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-07-31

Brief Summary

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

Conditions

Terlipressin; Blood Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Terlipressin

Intervention Type: DRUG

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.)

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)

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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.

Interventions

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.)

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

glypressin; 0.9 Nacl

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Magdy Mohammed Mahdy Sayed

Assiut-Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assiut University hospital Egypt, Egypt

Role: STUDY_DIRECTOR

Assiut University

Other Identifiers

ABC-223-DE

Identifier Type: -

Identifier Source: org_study_id