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
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Output, Low||Drug: adrenaline Drug: milrinone||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||April 2007|
- Plasma lactate concentration in the immediate postoperative period
- Plasma pyruvate
- Plasma glucose
- Plasma creatinine
- Urinary excretion of alpha-1-microglobulin
- Plasma cystatin C
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
|Principal Investigator:||Matthias Heringlake, MD||Department of Anesthesiology, University of Luebeck|