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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction

Conditions
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Cardiac Output, Low

Intervention / Treatment
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* Drug: adrenaline
* Drug: milrinone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adrenaline|nan|
|Drug: milrinone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lactate concentration in the immediate postoperative period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamics |  |  | 
| Plasma pyruvate |  |  | 
| Plasma glucose |  |  | 
| Plasma creatinine |  |  | 
| Urinary excretion of alpha-1-microglobulin |  |  | 
| Plasma cystatin C |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery bypass grafting, inotropes, metabolism, renal failure