Clinical trial NCT00446017: The Effects of Adrenaline and Milrinone in Patients With Myocardial Dysfunction After CABG
Official title: Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Output, Low
Keywords: coronary artery bypass grafting
inotropes
metabolism
renal failure
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Deutsche Stiftung für Herzforschung
First posted: 2007-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 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

Primary outcomes:
measure: Plasma lactate concentration in the immediate postoperative period
Secondary outcomes:
measure: Hemodynamics
measure: Plasma pyruvate
measure: Plasma glucose
measure: Plasma creatinine
measure: Urinary excretion of alpha-1-microglobulin
measure: Plasma cystatin C
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology, University of Luebeck
name: Matthias Heringlake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heringlake M, Wernerus M, Grunefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schon 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. doi: 10.1186/cc5904.