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
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
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
NCT ID
NCT00446017
First Posted
March 9, 2007
Last Updated
June 2, 2015
Sponsor
University of Luebeck
Collaborators
Deutsche Stiftung für Herzforschung
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
Learn more about this trial
The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
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