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

Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572088
• Other study ID #: ABC-223-DE
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: July 2017

Study information

• Verified date: May 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss
• Hemorrhage
• Terlipressin

Intervention

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.)
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative blood loss	Amount of intraoperative blood loss in ml	intaoperative periods
Secondary	Patients needing blood transfusion	Number of patients needing blood transfusion	intaoperative periods
Secondary	Red blood cell units transfused	The number of red blood cell units transfused	intaoperative periods
Secondary	portal pressure changes	portal pressure changes in mmHg	intaoperative periods
Secondary	ICU stay	ICU stay in days	postoperative periods