General AnesthesiaPhase 4DOBU whippleNCT04893655
Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy
A Phase 4 study testing Dobutamine Hydrochloride in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Dobutamine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Sep 2021to 25 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Sepsis.
- BMI > 40.
- Severe coagulopathy (INR > 2).
- Thrombocytopenia (< 80 x 103 /mcL).
- End stage liver disease and/or portal hypertension.
- Pregnancy and breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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
- Being tested
- Dobutamine Hydrochloride
- Keywords
- hepatic blood flow, dobutamine, hepatic vascular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dobutamine HydrochlorideDrug
dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Dobutamine | Experimental | dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min Receives: Drug: Dobutamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine
flow measurements with echo probe
Measured: 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
Measured: 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
change in cardiac index (measurements with PiCCO catheter)
Measured: 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
change in systemic vascular resistance (SVR)
Measured: 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
change in portal venous resistance (PVR)
Measured: 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
change in heart rate (measurements with PiCCO catheter)
Measured: 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
change in blood pressure (measurements with PiCCO catheter)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :central venous pressure, during goal-directed hemodynamic therapy with dobutamine
change in cardiac index (measurements with central line)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :pulse pressure variation, during goal-directed hemodynamic therapy with dobutamine
change in pulse pressure variation (measurements with PiCCO catheter)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :stroke volume variation, during goal-directed hemodynamic therapy with dobutamine
change in stroke volume variation (measurements with PiCCO catheter)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements : Systemic Vascular Resistance Index (SVRI), during goal-directed hemodynamic therapy with dobutamine
change in Systemic Vascular Resistance Index (SVRI) (measurements with PiCCO catheter)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements : Left Ventricular contractility (dPmx), during goal-directed hemodynamic therapy with dobutamine
change in Left Ventricular contractility (dPmx) (measurements with PiCCO catheter)
Measured: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start14 Sep 2021
- Primary completion24 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jurgen Van Limmen, MD, Principal investigator, UZ Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893655
- Sponsor's protocol ID
- BC-08919
- Acronym
- DOBU whipple
- Status last verified
- Jul 2023
- First submitted
- 30 Apr 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy
- ClinicalTrials.gov ID
- NCT04893655
- Acronym / sponsor ID
- DOBU whipple / BC-08919
- Conditions
- General Anesthesia
- Keywords
- hepatic blood flow, dobutamine, hepatic vascular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 24 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dobutamine | Experimental | Drug: Dobutamine Hydrochloridedobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- Allergy to the medication dobutamine.
- Renal insufficiency (SCr > 2 mg/dL).
- Severe heart failure (EF < 25%).
- Hemodynamic unstable patients.
- Atrial fibrillation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dobutamine Hydrochloridedobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min | Drug | Dobutamine |
Primary outcome
change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
flow measurements with echo probe
Changes in portal vein and caval vein pressures before and after dobutamine infusion
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
pressure measurements with 25gauge needle
10 secondary outcomes
change in systemic hemodynamic measurements :cardiac index, during goal-directed hemodynamic therapy with dobutamine
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :central venous pressure, during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :pulse pressure variation, during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements :stroke volume variation, during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements : Systemic Vascular Resistance Index (SVRI), during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
change in systemic hemodynamic measurements : Left Ventricular contractility (dPmx), during goal-directed hemodynamic therapy with dobutamine
Time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jurgen Van Limmen, MD principal investigator
UZ Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dobutamine Hydrochloride in people with General Anesthesia, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in portal and arterial hepatic blood flow during goal-directed hemodynamic therapy with dobutamine (time frame: from start anesthesia until end of anesthesia, up to a maximum of 11 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.