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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Luebeck

Current Primary Outcome: Plasma lactate concentration in the immediate postoperative period

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hemodynamics
  • Plasma pyruvate
  • Plasma glucose
  • Plasma creatinine
  • Urinary excretion of alpha-1-microglobulin
  • Plasma cystatin C


Original Secondary Outcome: Same as current

Information By: University of Luebeck

Dates:
Date Received: March 9, 2007
Date Started: June 2003
Date Completion:
Last Updated: June 2, 2015
Last Verified: April 2007