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

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ClinicalTrials.gov Identifier: NCT03572088

Recruitment Status : Completed

First Posted : June 28, 2018

Last Update Posted : June 28, 2018

Sponsor:

Information provided by (Responsible Party):

Magdy Mohammed Mahdy Sayed, Assiut University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Terlipressin Blood Loss	Drug: Terlipressin Drug: normal saline	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Actual Study Start Date :	May 2016
Actual Primary Completion Date :	July 2017
Actual Study Completion Date :	July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Blood Transfusion and Donation

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	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.) Other Name: glypressin
Placebo Comparator: 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)	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. Other Name: 0.9 Nacl

Arm

Intervention/treatment

Active Comparator: 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.

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.)

Other Name: glypressin

Placebo Comparator: 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)

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.

Other Name: 0.9 Nacl

Outcome Measures

Primary Outcome Measures :

Intraoperative blood loss [ Time Frame: intaoperative periods ]
Amount of intraoperative blood loss in ml

Secondary Outcome Measures :

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 Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03572088

Sponsors and Collaborators

Assiut University

Investigators

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Study Director:	Assiut University hospital Egypt, Egypt	Assiut University

More Information

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Responsible Party:	Magdy Mohammed Mahdy Sayed, Assiut-Egypt, Assiut University
ClinicalTrials.gov Identifier:	NCT03572088
Other Study ID Numbers:	ABC-223-DE
First Posted:	June 28, 2018 Key Record Dates
Last Update Posted:	June 28, 2018
Last Verified:	June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Additional relevant MeSH terms:

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Hemorrhage Pathologic Processes Terlipressin Antihypertensive Agents Vasoconstrictor Agents

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