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Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.

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ClinicalTrials.gov Identifier: NCT03965117
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:

Maintaining adequate blood pressure is important for survival of organs. Recent studies have demonstrated that higher blood pressures were necessary for prevention of acute kidney injury and myocardial injury after non-cardiac surgery. Hypotension after induction and maintenance of anesthesia is common. For maintaining adequate blood pressure in a euvolemic patient, vasopressor therapy is required. Norepinephrine (NOR) is commonly used to treat anesthesia-related hypotension.

The hepatic circulation has a large number of alpha and beta adrenergic receptors and is very sensitive for adrenergic stimulation such as norepinephrine infusion. Animal studies (Hiltebrand et al.) suggest that NOR has only minimal effect on hepatic blood flow however the effect of NOR on hepatic blood flow in clinical surgical patients remains unclear.

The aim of the study is to evaluate the effect of NOR on hepatic blood flow during.

goal directed haemodynamic therapy.


Condition or disease Intervention/treatment Phase
General Anesthesia Drug: Norepinephrine Phase 4

Detailed Description:

All patients receive standardized anesthesia care for pancreas surgery according to the existing departmental protocol for these interventions.

All patients receive individualized goal-directed haemodynamic therapy based on the transpulmonary thermodilution technique.

At designated times, hemodynamic variables will be recorded. These include:

  • Heart rate (bpm)
  • Central venous pressure (mmHg)
  • Mean arterial pressure (mmHg)
  • Cardiac index (L/min/m2)
  • Pulse pressure variation (PPV)

Blood flow and pressure measurements performed by the surgeon :

  • Hepatic flow : hepatic artery (HAF) and portal vein (PVF)
  • Pressure measurements in portal vein (PPorta) and caval vein (PCava)

Both flow and pressure will be simultaneously recorded. To minimize the effect of ventilation on pressure, these measurements will be obtained during apnea.

Between each flow measurement there will be a minimum of 5 minutes.

NOR will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), NOR is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of Norepinephrine Infusion on Hepatic Blood Flow During Goal-directed Haemodynamic Therapy.
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: norepinephrine
norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect.
Drug: Norepinephrine
norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), norepinephrine is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).




Primary Outcome Measures :
  1. change in hepatic blood flow during goal-directed hemodynamic therapy with norepinphrine [ Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours ]
    flow measurements with echo probe

  2. change in hepatic blood pressures during goal-directed hemodynamic therapy with norepinphrine [ Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours ]
    pressure measurements with needle


Secondary Outcome Measures :
  1. change in systemic vascular resistance (SVR), during goal-directed hemodynamic therapy with norepinphrine [ Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours ]
    change in systemic vascular resistance (SVR)

  2. change in portal venous resistance (PVR) during goal-directed hemodynamic therapy with norepinphrine [ Time Frame: From start anesthesia until end of anesthesia up to a maximum of 11 hours ]
    change in portal venous resistance (PVR)

  3. change in cardiac index during goal-directed hemodynamic therapy with norepinphrine [ Time Frame: From start anesthesia until end of anesthesia, up to a maximum of 11 hours ]
    change in cardiac index

  4. amount of blood loss [ Time Frame: from start of surgery until end of surgery, up to a maximum of 10 hours ]
    amount of blood loss at end of surgery

  5. amount of fluids given during surgery with goal-directed hemodynamic therapy with norepinphrine [ Time Frame: from start of surgery until end of surgery up to a maximum of 10 hours ]
    total amount of cristalloids and colloids given during surgery



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 pancreatic surgery.

Exclusion Criteria:

  • Allergy to the medication.
  • Renal insufficiency (SCr > 2 mg/dL).
  • Severe heart failure (EF < 25%).
  • Hemodynamic instable patients.
  • Atrial fibrillation.
  • Sepsis.
  • BMI > 40.
  • Severe coagulopathy (INR > 2).
  • Thrombocytopenia (< 80 x 103 /mcL).
  • End stage liver disease.
  • Pregnancy and breastfeeding women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965117


Contacts
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Contact: Jurgen Van Limmen, MD 09/332 32 81 ext 09 Jurgen.vanlimmen@Ugent.be
Contact: Ann De Bruyne 09/332 59 33 ext 09 Jurgen.vanlimmen@Ugent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Jurgen Van Limmen, MD    09/332 32 81 ext 09    Jurgen.vanlimmen@Ugent.be   
Contact: Ann De Bruyne    09/332 59 33 ext 09    Ann.debruyne@Ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Jurgen Van Limmen, MD UZ Ghent
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03965117    
Other Study ID Numbers: 2019/0395
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
hepatic blood flow
Norepinephrine
hepatic vascular pressure
Additional relevant MeSH terms:
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Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents