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

This study has been completed.
Deutsche Stiftung für Herzforschung
Information provided by:
University of Luebeck Identifier:
First received: March 9, 2007
Last updated: June 2, 2015
Last verified: April 2007
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.

Condition Intervention Phase
Cardiac Output, Low
Drug: adrenaline
Drug: milrinone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction

Resource links provided by NLM:

Further study details as provided by University of Luebeck:

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

Estimated Enrollment: 60
Study Start Date: June 2003
Study Completion Date: April 2007
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00446017

Sponsors and Collaborators
University of Luebeck
Deutsche Stiftung für Herzforschung
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00446017     History of Changes
Other Study ID Numbers: HL-ANAE-101
Study First Received: March 9, 2007
Last Updated: June 2, 2015

Keywords provided by University of Luebeck:
coronary artery bypass grafting
renal failure

Additional relevant MeSH terms:
Cardiac Output, Low
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms
Epinephryl borate
Cardiotonic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Vasoconstrictor Agents processed this record on April 28, 2017