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

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

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

Conditions
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Terlipressin, Blood Loss

Intervention / Treatment
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* Drug: Terlipressin
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Terlipresssin<br>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<br>* 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.)<br>* Other names: glypressin;|
| Placebo Comparator: Control<br>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<br>* 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.<br>* Other names: 0.9 Nacl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative blood loss | Amount of intraoperative blood loss in ml | intaoperative periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients needing blood transfusion | Number of patients needing blood transfusion | intaoperative periods | 
| Red blood cell units transfused | The number of red blood cell units transfused | intaoperative periods | 
| portal pressure changes | portal pressure changes in mmHg | intaoperative periods | 
| ICU stay | ICU stay in days | postoperative periods |