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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00446017
Acronym
AMORI
Enrollment
60
Registered
2007-03-12
Start date
2003-06-30
Completion date
2007-04-30
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Output, Low

Keywords

coronary artery bypass grafting, inotropes, metabolism, renal failure

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.

Interventions

DRUGadrenaline
DRUGmilrinone

Sponsors

Deutsche Stiftung für Herzforschung
CollaboratorOTHER
University of Luebeck
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Plasma lactate concentration in the immediate postoperative period

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026