Current partner codePEPTIDESDE
NCT03572088·Phase 2·INTERVENTIONAL

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

Status

Completed

Phase

Phase 2

Enrollment

40

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Interventions

Treatment arms and agents.

DRUG

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.)

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.

Timeline

From registration to results.

  1. First posted

    Jun 28, 2018

  2. Study start

    May 2016

  3. Primary completion

    Jul 2017

  4. Study completion

    Jul 2017

  5. Results posted

    Not reported

  6. Registry updated

    May 22, 2023

Outcomes

What the study measures.

Primary outcomes

Intraoperative blood loss

Time frame · intaoperative periods

Amount of intraoperative blood loss in ml

Secondary outcomes

Patients needing blood transfusion

Time frame · intaoperative periods

Number of patients needing blood transfusion

Red blood cell units transfused

Time frame · intaoperative periods

The number of red blood cell units transfused

portal pressure changes

Time frame · intaoperative periods

portal pressure changes in mmHg

ICU stay

Time frame · postoperative periods

ICU stay in days

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.