Evaluating hepatic blood flow and caval & portal vein pressures during goal-directed hemodynamic therapy in patients undergoing pancreaticoduodenectomy.
Conditions
Interventions
Trade Name: Dobutamine EG 250 mg/20 ml concentraat voor oplossing voor infusie.
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: DOBUTAMINE
CAS Number: 34368-04-2
Conce
Sponsors
UZ Gent
Eligibility
Sex/Gender
All
Inclusion criteria
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). 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
Exclusion criteria
Exclusion criteria: • Allergy to the medication dobutamine. • Renal insufficiency (SCr > 2 mg/dL). • Severe heart failure (EF 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
| Measure | Time frame |
|---|---|
| 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. 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 T2 - Dobutamine infusion at 2 mcg/kg/min T3 - After minimum 10 minutes, infusion will be set at 5 mcg/kg/min T4 - final hepatic blood flow will be recorded | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). 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. T1 – after pancreaticoduodenectomy, at baseline without dobutamine infusion. T3 – after minimum 10 minutes of infusion of dobutamine at 2 mcg/kg/min, before raising dobutamine infusion to 5 mcg/kg/min T2 through T4 – a measurement will be made every minute (together with the hepatic blood flow measurements) T4 – before surgical reconstruction, after minimum 10 minutes of infusion of dobutamine at 5 mcg/kg/min. T5 – end of surgery. | — |
Countries
Belgium
Contacts
Public ContactHiruz CTU
Ghent University Hospital
Outcome results
None listed