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| Sponsors and Collaborators: |
University of Luebeck German Foundation for Heart Research |
|---|---|
| Information provided by: | University of Luebeck |
| ClinicalTrials.gov Identifier: | NCT00446017 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Output, Low |
Drug: adrenaline Drug: milrinone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Phase 3 Study of Adrenaline and Milrinone in Patients With Myocardial Dysfunction |
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | December 2007 |
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| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | HL-ANAE-101 |
| Study First Received: | March 9, 2007 |
| Last Updated: | April 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00446017 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
coronary artery bypass grafting inotropes metabolism renal failure |
|
Signs and Symptoms Heart Diseases Milrinone |
Epinephrine Cardiac Output, Low Kidney Failure |
|
Respiratory System Agents Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Cardiotonic Agents Physiological Effects of Drugs Hematologic Agents Adrenergic Agonists Therapeutic Uses Vasoconstrictor Agents Cardiovascular Diseases Adrenergic alpha-Agonists |
Adrenergic beta-Agonists Sympathomimetics Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Pharmacologic Actions Mydriatics Phosphodiesterase Inhibitors Autonomic Agents Platelet Aggregation Inhibitors Peripheral Nervous System Agents Bronchodilator Agents |
