Cardiac Output, Low Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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