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

NCT ID: NCT04893655

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-14
• Study Completion Date: 2023-07-25

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

Conditions

General Anesthesia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dobutamine

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

Group Type: EXPERIMENTAL

Dobutamine Hydrochloride

Intervention Type: DRUG

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

Interventions

Dobutamine Hydrochloride

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jurgen Van Limmen, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

BC-08919

Identifier Type: -

Identifier Source: org_study_id