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The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG (AMORI)

Primary Purpose

Cardiac Output, Low

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
adrenaline
milrinone
Sponsored by
University of Luebeck
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Output, Low focused on measuring coronary artery bypass grafting, inotropes, metabolism, renal failure

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (MAP) after elective coronary artery bypass grafting

Exclusion Criteria:

  • intraoperative use of diuretics or hydroxyethylstarch

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Plasma lactate concentration in the immediate postoperative period

    Secondary Outcome Measures

    Hemodynamics
    Plasma pyruvate
    Plasma glucose
    Plasma creatinine
    Urinary excretion of alpha-1-microglobulin
    Plasma cystatin C

    Full Information

    First Posted
    March 9, 2007
    Last Updated
    June 2, 2015
    Sponsor
    University of Luebeck
    Collaborators
    Deutsche Stiftung für Herzforschung
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00446017
    Brief Title
    The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
    Acronym
    AMORI
    Official Title
    Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2003 (undefined)
    Primary Completion Date
    August 2004 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Luebeck
    Collaborators
    Deutsche Stiftung für Herzforschung

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Myocardial dysfunction necessitating inotropic support is a typical complication after on-pump cardiac surgery. This prospective, randomized pilot-study analyses the metabolic and renal effects of the inotropes adrenaline and milrinone in patients needing inotropic support after coronary-artery-bypass-grafting. With respect to data derived from patients with sepsis shock and results from studies using phosphodiesterase-inhibitors prophylactically, the hypothesis is tested that adrenaline may be associated with unwarranted metabolic effects (hyperlactatemia and hyperglycemia) and renal dysfunction.
    Detailed Description
    Following preoperative written informed consent, patients presenting with a cardiac-index (CI) < 2.2 l/min/m2 upon ICU-admission - despite adequate mean arterial (titrated with noradrenaline or sodium-nitroprusside) and filling pressures - will be randomized to 14 hour treatment with adrenaline or milrinone to achieve a CI > 3.0 l/min/m2. A group of patients not needing inotropes will be used as controls. Hemodynamics, metabolism (plasma lactate, pyruvate, glucose, acid-base status, insulin requirements) and renal function (urinary excretion of alpha-1-microglobulin, creatinine clearance, plasma cystatin-C levels) will be determined during the treatment period and up to 48 hours after surgery (follow up period). The study is designed as a pilot study including 20 patients per group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiac Output, Low
    Keywords
    coronary artery bypass grafting, inotropes, metabolism, renal failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    adrenaline
    Intervention Type
    Drug
    Intervention Name(s)
    milrinone
    Primary Outcome Measure Information:
    Title
    Plasma lactate concentration in the immediate postoperative period
    Secondary Outcome Measure Information:
    Title
    Hemodynamics
    Title
    Plasma pyruvate
    Title
    Plasma glucose
    Title
    Plasma creatinine
    Title
    Urinary excretion of alpha-1-microglobulin
    Title
    Plasma cystatin C

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: cardiac index below 2.2 l/min/m2 upon intensive care unit admission despite optimized filling pressures and normalized mean arterial blood pressure (MAP) after elective coronary artery bypass grafting Exclusion Criteria: intraoperative use of diuretics or hydroxyethylstarch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Matthias Heringlake, MD
    Organizational Affiliation
    Department of Anesthesiology, University of Luebeck
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17470271
    Citation
    Heringlake M, Wernerus M, Grunefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schon J. The metabolic and renal effects of adrenaline and milrinone in patients with myocardial dysfunction after coronary artery bypass grafting. Crit Care. 2007;11(2):R51. doi: 10.1186/cc5904.
    Results Reference
    derived

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    The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG

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