Back to resultsEffects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
Primary Purpose
Hepatectomy, Surgical Blood Loss, Terlipressin
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Terlipressin
normal saline
Sponsored by
About this trial
This is an interventional prevention trial for Hepatectomy, Surgical Blood Loss, Terlipressin focused on measuring Hepatectomy, Surgical Blood Loss, terlipressin
Eligibility Criteria
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
Sites / Locations
- Assiut University hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Terlipressin
Control
Arm Description
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(1 mg over 30 mins) followed by a continuous infusion of 2μg/kg/h to be continued throughout the surgery then gradually withdrawn over 4 hours
same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.
Outcomes
Primary Outcome Measures
blood loss
blood loss in ml
Secondary Outcome Measures
blood units transfused
number of packed RBCs units transfused
lactate level
lactate level in blood gas sample in mmol/L
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02588716
Brief Title
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
Official Title
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effects of Terlipressin infusion on blood loss & transfusion requirements in cirrhotic patients undergoing major liver resections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatectomy, Surgical Blood Loss, Terlipressin
Keywords
Hepatectomy, Surgical Blood Loss, terlipressin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Terlipressin
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
same volumes of normal saline with the same rate of infusion, throughout the operation then gradually withdrawn over 4 hours.
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
glipressin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.
Primary Outcome Measure Information:
Title
blood loss
Description
blood loss in ml
Time Frame
intraoperative period
Secondary Outcome Measure Information:
Title
blood units transfused
Description
number of packed RBCs units transfused
Time Frame
intraoperative period
Title
lactate level
Description
lactate level in blood gas sample in mmol/L
Time Frame
at start and end of resection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut University hospital
City
Assiut
State/Province
Asyut Governorate
ZIP/Postal Code
11111
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
30079635
Citation
Abbas MS, Mohamed KS, Ibraheim OA, Taha AM, Ibraheem TM, Fadel BA, Elawamy A, Abbas AM. Effects of terlipressin infusion on blood loss and transfusion needs during liver resection: A randomised trial. Acta Anaesthesiol Scand. 2019 Jan;63(1):34-39. doi: 10.1111/aas.13226. Epub 2018 Aug 5.
Results Reference
derived
Learn more about this trial
Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.
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