Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Assiut University

Status and phase: Completed; Phase 2

Conditions: Hemodynamics, Liver, Terlipressin

Treatments: Drug: normal saline; Drug: terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT02718599

ABC-123-DE

Details and patient eligibility

About

To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age > 18 years.
• Any gender.
• ASA (American Society of Anesthesiologists) Classification( Class I-II)
• Patients undergoing major elective hepatobiliary surgery.

Exclusion criteria

• Preoperative renal failure (GFR < 50 ml/min).
• Severe liver dysfunction (Child- turcotte -Pugh grade C).
• Hyponatremia (<132 mmol/l).
• Severe aortic regurgitation, severe mitral regurgitation, 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 >160/100 mmHg despite intensive treatment).
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Terlipressin

Active Comparator group

Description:

Terlipressin will be 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.

Treatment:

Drug: terlipressin

CONTROL

Placebo Comparator group

Description:

Patients receive the same volume of 0.9% saline in place of terlipressin 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