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

NCT04893655 | Completed Phase 4 DMC

• 1 other identifier: BC-08919
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthesia

Keywords

hepatic blood flow; dobutamine; hepatic vascular pressure

Outcome Measures

Primary Outcomes (2)

• change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine

  flow measurements with echo probe

  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

  pressure measurements with 25gauge needle

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

Secondary Outcomes (10)

• change in systemic hemodynamic measurements :cardiac index, during goal-directed hemodynamic therapy with dobutamine

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

• change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with dobutamine

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

• change in portal venous resistance (PVR), during goal-directed hemodynamic therapy with dobutamine

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

• change in systemic hemodynamic measurements :heart rate, during goal-directed hemodynamic therapy with dobutamine

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

• change in systemic hemodynamic measurements :blood pressure, during goal-directed hemodynamic therapy with dobutamine

  from start anesthesia until end of anesthesia, up to a maximum of 11 hours

Study Arms (1)

Dobutamine

EXPERIMENTAL

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

Drug: Dobutamine Hydrochloride

Interventions

Dobutamine Hydrochloride DRUG

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

Dobutamine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Dobutamine

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Jurgen Van Limmen, MD

  UZ Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 19, 2021
• Study Start: September 14, 2021
• Primary Completion: July 24, 2023
• Study Completion: July 25, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)