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

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ClinicalTrials.gov Identifier: NCT00446017
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : June 3, 2015
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Cardiac Output, Low Drug: adrenaline Drug: milrinone Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
Study Start Date : June 2003
Primary Completion Date : August 2004
Study Completion Date : April 2007


Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Plasma lactate concentration in the immediate postoperative period

Secondary Outcome Measures :
  1. Hemodynamics
  2. Plasma pyruvate
  3. Plasma glucose
  4. Plasma creatinine
  5. Urinary excretion of alpha-1-microglobulin
  6. Plasma cystatin C

Eligibility Criteria

Information from the National Library of Medicine

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

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): NCT00446017


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00446017     History of Changes
Other Study ID Numbers: HL-ANAE-101
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: April 2007

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

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