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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03572088

Collaborator

(none)

Enrollment

Arms

Actual Duration (Months)

Study Details

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

Study Type:

Interventional

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 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Jul 1, 2017

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 Names: 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 Names: 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 Names:

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 Names:

0.9 Nacl

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Patients needing blood transfusion [intaoperative periods]
Number of patients needing blood transfusion
Red blood cell units transfused [intaoperative periods]
The number of red blood cell units transfused
portal pressure changes [intaoperative periods]
portal pressure changes in mmHg
ICU stay [postoperative periods]
ICU stay in days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Assiut University hospital Egypt, Egypt, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magdy Mohammed Mahdy Sayed, Assiut-Egypt, Assiut University

ClinicalTrials.gov Identifier:

NCT03572088

Other Study ID Numbers:

ABC-223-DE

First Posted:

Jun 28, 2018

Last Update Posted:

Jun 28, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hemorrhage

Terlipressin

Study Results

No Results Posted as of Jun 28, 2018