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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03572088
Enrollment
40
Registered
2018-06-28
Start date
2016-05-31
Completion date
2017-07-31
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Terlipressin

Brief summary

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

Interventions

DRUGnormal 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.

DRUGTerlipressin

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.)

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative blood lossintaoperative periodsAmount of intraoperative blood loss in ml

Secondary

MeasureTime frameDescription
Patients needing blood transfusionintaoperative periodsNumber of patients needing blood transfusion
Red blood cell units transfusedintaoperative periodsThe number of red blood cell units transfused
portal pressure changesintaoperative periodsportal pressure changes in mmHg
ICU staypostoperative periodsICU stay in days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026