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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446017
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : June 3, 2015
Deutsche Stiftung für Herzforschung
Information provided by:
University of Luebeck

March 9, 2007
March 12, 2007
June 3, 2015
June 2003
August 2004   (Final data collection date for primary outcome measure)
Plasma lactate concentration in the immediate postoperative period
Same as current
Complete list of historical versions of study NCT00446017 on Archive Site
  • Hemodynamics
  • Plasma pyruvate
  • Plasma glucose
  • Plasma creatinine
  • Urinary excretion of alpha-1-microglobulin
  • Plasma cystatin C
Same as current
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The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
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.

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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cardiac Output, Low
  • Drug: adrenaline
  • Drug: milrinone
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Heringlake M, Wernerus M, Grünefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schön 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2007
August 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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University of Luebeck
Deutsche Stiftung für Herzforschung
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
University of Luebeck
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP