Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

March 9, 2007
April 19, 2007
June 2003
Not Provided
Plasma lactate concentration in the immediate postoperative period
Same as current
Complete list of historical versions of study NCT00446017 on ClinicalTrials.gov Archive Site
  • Hemodynamics
  • Plasma pyruvate
  • Plasma glucose
  • Plasma creatinine
  • Urinary excretion of alpha-1-microglobulin
  • Plasma cystatin C
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Cardiac Output, Low
  • Drug: adrenaline
  • Drug: milrinone
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
60
December 2007
Not Provided

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00446017
HL-ANAE-101
No
Not Provided
University of Luebeck
German Foundation for Heart Research
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