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

NCT00446017 | Completed Phase 3

• 1 other identifier: HL-ANAE-101
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cardiac Output, Low

Keywords

coronary artery bypass grafting; inotropes; metabolism; renal failure

Outcome Measures

Primary Outcomes (1)

• Plasma lactate concentration in the immediate postoperative period

Secondary Outcomes (6)

• Hemodynamics

• Plasma pyruvate

• Plasma glucose

• Plasma creatinine

• Urinary excretion of alpha-1-microglobulin

Interventions

adrenaline DRUG

milrinone DRUG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• intraoperative use of diuretics or hydroxyethylstarch

Sponsors & Collaborators

• University of Luebeck: lead
• Deutsche Stiftung für Herzforschung: collaborator

Related Publications (1)

• Heringlake M, Wernerus M, Grunefeld J, Klaus S, Heinze H, Bechtel M, Bahlmann L, Poeling J, Schon J. The metabolic and renal effects of adrenaline and milrinone in patients with myocardial dysfunction after coronary artery bypass grafting. Crit Care. 2007;11(2):R51. doi: 10.1186/cc5904.

  PMID: 17470271 DERIVED

MeSH Terms

Conditions

Cardiac Output, Low; Renal Insufficiency

Interventions

Epinephrine; Milrinone

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Amrinone; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthias Heringlake, MD

  Department of Anesthesiology, University of Luebeck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 9, 2007
• First Posted: March 12, 2007
• Study Start: June 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: April 1, 2007
• Last Updated: June 3, 2015

Record last verified: 2007-04