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Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy

Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04893655
Acronym
DOBU whipple
Enrollment
58
Registered
2021-05-19
Start date
2021-09-14
Completion date
2023-07-25
Last updated
2023-08-01

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

Conditions

General Anesthesia

Keywords

hepatic blood flow, dobutamine, hepatic vascular pressure

Brief summary

Maintaining adequate perfusion pressure and oxygen supply is essential for organ survival. Splanchnic hypoperfusion during the perioperative period in abdominal surgery may result in mucosal ischemia with increased permeability of the gut barrier. Additionally, the liver is also sensitive for hypoxemia and hypoperfusion, especially during liver surgery. Anesthetics (such as propofol or sevoflurane) have a cardiovascular depressant effect, resulting in a reduction of cardiac output (CO). Dobutamine is used to counteract myocardial depressant effect of anesthetics. Additionally, dobutamine is frequently used during abdominal surgery to maintain splanchnic perfusion. Dobutamine could increase hepatic blood flow (HBF) indirectly by increasing cardiac output or directly by stimulating adrenergic receptors in the splanchnic circulation. The hepatic circulation has a large number of alpha and beta adrenergic receptors and could be sensitive for adrenergic stimulation such as dobutamine. Hence, dobutamine could have a direct effect on the hepatic vasculature. The aim of the study is to evaluate the effect of dobutamine on hepatic blood flow during goal directed hemodynamic therapy and to distinguish between potential direct and indirect effects.

Detailed description

All patients receive standardized anesthesia care for pancreaticoduodenectomy according to the existing departmental protocol for these interventions. All patients receive individualized goal-directed hemodynamic therapy based on the transpulmonary thermodilution technique. At designated times, hemodynamic variables will be recorded. These include : * Heart rate (bpm) * Central venous pressure (mmHg) * Systolic arterial pressure (mmHg) * Diastolic arterial pressure (mmHg) * Mean arterial pressure (mmHg) * Cardiac index (L/min/m2) * Pulse pressure variation (PPV) * Stroke volume variation (SVV) Measurements of hepatic flow and pressure will be performed by the surgeon : * Hepatic flow : in the hepatic artery (arterial HBF) and portal vein (portal HBF). * Pressure measurements : in portal vein (PPorta) and caval vein (PCava) Measurements will be done : * without inotropic support * with infusion of dobutamine 2mcg/kg/min * with infusion of dobutamine 5mcg/kg/min

Interventions

dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult ≥ 18 years ≤ 80 years (female or male). * ASA I - II - III. * Able to comprehend, sign and date the written informed consent document to participate in the clinical trial. * Patient is scheduled for pancreaticoduodenectomy (Whipple's procedure).

Exclusion criteria

* Allergy to the medication dobutamine. * Renal insufficiency (SCr \> 2 mg/dL). * Severe heart failure (EF \< 25%). * Hemodynamic unstable patients. * Atrial fibrillation. * Sinus tachycardia \> 100 bpm on pre-operative electrocardiogram. * Sepsis. * BMI \> 40. * Severe coagulopathy (INR \> 2). * Thrombocytopenia (\< 80 x 103 /mcL). * End stage liver disease and/or portal hypertension. * Pregnancy and breastfeeding women.

Design outcomes

Primary

MeasureTime frameDescription
change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hoursflow measurements with echo probe
Changes in portal vein and caval vein pressures before and after dobutamine infusionfrom start anesthesia until end of anesthesia, up to a maximum of 11 hourspressure measurements with 25gauge needle

Secondary

MeasureTime frameDescription
change in portal venous resistance (PVR), during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in portal venous resistance (PVR)
change in systemic hemodynamic measurements :heart rate, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in heart rate (measurements with PiCCO catheter)
change in systemic hemodynamic measurements :blood pressure, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in blood pressure (measurements with PiCCO catheter)
change in systemic hemodynamic measurements :central venous pressure, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in cardiac index (measurements with central line)
change in systemic hemodynamic measurements :cardiac index, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in cardiac index (measurements with PiCCO catheter)
change in systemic hemodynamic measurements :stroke volume variation, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in stroke volume variation (measurements with PiCCO catheter)
change in systemic hemodynamic measurements : Systemic Vascular Resistance Index (SVRI), during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in Systemic Vascular Resistance Index (SVRI) (measurements with PiCCO catheter)
change in systemic hemodynamic measurements : Left Ventricular contractility (dPmx), during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in Left Ventricular contractility (dPmx) (measurements with PiCCO catheter)
change in systemic hemodynamic measurements :pulse pressure variation, during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in pulse pressure variation (measurements with PiCCO catheter)
change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with dobutaminefrom start anesthesia until end of anesthesia, up to a maximum of 11 hourschange in systemic vascular resistance (SVR)

Countries

Belgium

Outcome results

None listed

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