NCT00446017

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: University of Luebeck · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiac Output, Low

Interventions

Type	Name	Description
DRUG	adrenaline
DRUG	milrinone

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-08-01
• Completion: 2007-04-01
• First posted: 2007-03-12
• Last updated: 2015-06-03