Back to resultsTerlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Primary Purpose
Terlipressin, Blood Loss
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Terlipressin
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Terlipressin
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Terlipresssin
Control
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Intraoperative blood loss
Amount of intraoperative blood loss in ml
Secondary Outcome Measures
Patients needing blood transfusion
Number of patients needing blood transfusion
Red blood cell units transfused
The number of red blood cell units transfused
portal pressure changes
portal pressure changes in mmHg
ICU stay
ICU stay in days
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03572088
Brief Title
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Official Title
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Terlipressin, Blood Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Terlipresssin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Terlipressin
Other Intervention Name(s)
glypressin
Intervention Description
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.)
Intervention Type
Drug
Intervention Name(s)
normal saline
Other Intervention Name(s)
0.9 Nacl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
Amount of intraoperative blood loss in ml
Time Frame
intaoperative periods
Secondary Outcome Measure Information:
Title
Patients needing blood transfusion
Description
Number of patients needing blood transfusion
Time Frame
intaoperative periods
Title
Red blood cell units transfused
Description
The number of red blood cell units transfused
Time Frame
intaoperative periods
Title
portal pressure changes
Description
portal pressure changes in mmHg
Time Frame
intaoperative periods
Title
ICU stay
Description
ICU stay in days
Time Frame
postoperative periods
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assiut University hospital Egypt, Egypt
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs
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