Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02588716

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy, Surgical Blood Loss, Terlipressin	Drug: Terlipressin Drug: normal saline	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Terlipressin Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours	Drug: Terlipressin Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively. Other Names: glipressin
Placebo Comparator: Control same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.	Drug: normal saline Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Arm

Intervention/Treatment

Active Comparator: Terlipressin

Terlipressin will be given at the beginning of surgery as an initial bolus dose of (1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours

Drug: Terlipressin

Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.

Other Names:

glipressin

Placebo Comparator: Control

same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.

Drug: normal saline

Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.

Outcome Measures

Primary Outcome Measures

blood loss [intraoperative period]
blood loss in ml

Secondary Outcome Measures

blood units transfused [intraoperative period]
number of packed RBCs units transfused
lactate level [at start and end of resection]
lactate level in blood gas sample in mmol/L

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, American Society of Anesthesiology (ASA) classification class I and II and assigned for elective resection of 2 or more liver segments portal hypertension

Exclusion Criteria:

Patients with Child-Turcotte-Pugh grade B or C, clinically significant portal hypertension (splenomegaly, thrombocytopenia with platelets < 1011/L, esophageal varices grade 2 or more), Preoperative renal failure (GFR < 50ml/min), heart failure, Bradyarrhythmia (heart rate < 60/min), history of hemorrhagic stroke, Uncontrolled arterial hypertension (Blood pressure >160/100mmHg), and Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University hospital	Assiut	Asyut Governorate	Egypt	11111

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mostafa Samy Abbas, Lecturer, of Anesthesia & ICU, Assiut University, Assiut University

ClinicalTrials.gov Identifier:

NCT02588716

Other Study ID Numbers:

Terlipressin

First Posted:

Oct 28, 2015

Last Update Posted:

Dec 27, 2017

Last Verified:

Jul 1, 2015

Keywords provided by Mostafa Samy Abbas, Lecturer, of Anesthesia & ICU, Assiut University, Assiut University

Hepatectomy, Surgical Blood Loss, terlipressin

Additional relevant MeSH terms:

Hemorrhage

Blood Loss, Surgical

Terlipressin

Study Results

No Results Posted as of Dec 27, 2017