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

This study has suspended participant recruitment.
(Prespecified no. of patients could not be accomplished within 18 months)
Sponsor:
Collaborator:
German Foundation for Heart Research
Information provided by:
University of Luebeck
ClinicalTrials.gov Identifier:
NCT00446017
First received: March 9, 2007
Last updated: April 19, 2007
Last verified: April 2007
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00446017

Sponsors and Collaborators
University of Luebeck
German Foundation for Heart Research
Investigators
Principal Investigator: Matthias Heringlake, MD Department of Anesthesiology, University of Luebeck
  More Information

No publications provided by University of Luebeck

Additional 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
Study First Received: March 9, 2007
Last Updated: April 19, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on June 18, 2013