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Dobutamine Effect on Hepatic Blood Flow in Whipple Surgery
NCT04893655Phase 4
Key facts
- Status
- Completed
- Start
- Sep 2021
- Primary completion
- Jul 2023
- Countries
- 1
- Sponsor
- Ghent University Hospital
- Modality
- Small Molecules
- Drugs
- dobutamine
- Conditions
- splanchnic hypoperfusion
01
Overview
Phase 4, open-label, single-arm trial of dobutamine in splanchnic hypoperfusion, sponsored by Ghent University Hospital. Primary endpoints: Change in portal and arterial hepatic blood flow and Changes in portal vein and caval vein pressures. Started Sep 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Dobutamine
Sequential infusion of dobutamine at 2mcg/kg/min and 5mcg/kg/min
03
Who it enrols
Adult patients scheduled for pancreaticoduodenectomy (Whipple's procedure) with ASA I-III. Excludes patients with renal insufficiency, severe heart failure, hemodynamic instability, atrial fibrillation, sepsis, BMI > 40, severe coagulopathy, thrombocytopenia, or end-stage liver disease.
04
Endpoints
Primary
Change in portal and arterial hepatic blood flow
Changes in portal vein and caval vein pressures
Secondary
Change in cardiac index
Change in systemic vascular resistance
Change in portal venous resistance
Change in heart rate
Change in blood pressure
Change in central venous pressure
Change in pulse pressure variation
Change in stroke volume variation
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