Clinical trial

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

Name
BC-08919
Description
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.
Trial arms
Trial start
2021-09-14
Estimated PCD
2023-07-24
Trial end
2023-07-25
Status
Completed
Phase
Early phase I
Treatment
Dobutamine Hydrochloride
dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min
Arms:
Dobutamine
Size
58
Primary endpoint
change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine
from start anesthesia until end of anesthesia, up to a maximum of 11 hours
Changes in portal vein and caval vein pressures before and after dobutamine infusion
from start anesthesia until end of anesthesia, up to a maximum of 11 hours
Eligibility 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). 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 58, 'type': 'ACTUAL'}}
Updated at
2023-08-01

1 organization

1 product

1 indication

Product
Dobutamine