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

Phase 3

Completed

• Conditions: Cardiac Output, Low

• Registration Number: NCT00446017
• Lead Sponsor: University of Luebeck

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.

Study Timeline

• Study Start: 2003-06
• Primary Completion: 2004-08
• Study First Submitted: 2007-03-09
• Study First Submitted QC: 2007-03-09
• Study First Posted: 2007-03-12
• Status Verified: 2007-04
• Study Completion: 2007-04
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma lactate concentration in the immediate postoperative period

Secondary Outcome Measures

Name	Time	Method
Plasma pyruvate
Plasma glucose
Plasma creatinine
Urinary excretion of alpha-1-microglobulin
Plasma cystatin C
Hemodynamics