Clinical trial

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

NCT03572088

Name

ABC-223-DE

Description

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

Trial arms

Trial start

2016-05-01

Estimated PCD

2017-07-01

Trial end

2017-07-01

Status

Completed

Phase

Early phase I

Treatment

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.)

Arms:

Terlipresssin

Other names:

glypressin

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.

Arms:

Control

Other names:

0.9 Nacl

Size

Primary endpoint

Intraoperative blood loss

intaoperative periods

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2023-05-22

1 organization

1 product

1 drug

2 indications

Organization

Product

Indication

Indication

Drug