Effect of dobutamine on hepatic blood flow during goal-directed hemodynamic therapy.
- Conditions
- Evaluating hepatic blood flow and caval & portal vein pressures during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
- Registration Number
- EUCTR2020-005412-21-BE
- Lead Sponsor
- Z Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 70
•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).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
•Allergy to the medication dobutamine.
•Renal insufficiency (SCr > 2 mg/dL).
•Severe heart failure (EF < 25%).
•Hemodynamic unstable patients.
•Atrial fibrillation.
•Sinustachycardia > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the effect of dobutamine on hepatic blood flow and caval & portal vein pressures during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.;Secondary Objective: To assess the effects of dobutamine on systemic hemodynamics (CI, HR, SAP, DAP, MAP, CVP, SVV, PPV), systemic vascular resistance (SVR), SVRI, dPmx and portal venous resistance (PVR), cardiac index (CI), during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy. ;Primary end point(s): Changes in portal and arterial HBF during goal-directed hemodynamic therapy. <br>Changes in portal vein and caval vein pressures before and after dobutamine infusion. ;Timepoint(s) of evaluation of this end point: T1 - baseline measurements without inotropic support<br>T2 - Dobutamine infusion at 2 mcg/kg/min<br>T3 - After minimum 10 minutes, infusion will be set at 5 mcg/kg/min<br>T4 - final hepatic blood flow will be recorded
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The evaluation of the effect of dobutamine on systemic hemodynamic measurements (CI, HR, SAP, DAP, MAP, CVP, SVV, PPV), systemic vascular resistance (SVR), SVRI, dPmx and portal venous resistance (PVR).<br>The effect of dobutamine on hemodynamic data (HR, SAP, DAP, MAP, CI, PPV, SVV, CVP). ;Timepoint(s) of evaluation of this end point: T0 – start surgery.<br>T1 – after pancreaticoduodenectomy, at baseline without dobutamine infusion.<br>T3 – after minimum 10 minutes of infusion of dobutamine at 2 mcg/kg/min, before raising dobutamine infusion to 5 mcg/kg/min <br>T2 through T4 – a measurement will be made every minute (together with the hepatic blood flow measurements)<br>T4 – before surgical reconstruction, after minimum 10 minutes of infusion of dobutamine at 5 mcg/kg/min.<br>T5 – end of surgery.<br><br>