Skip to main content
OpenTrials
Completed

NCT Number: NCT00446017

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Output, Low Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenaline

Drug

Milrinone

Drug

Primary outcomes

  1. Plasma lactate concentration in the immediate postoperative period

Secondary outcomes

  1. Hemodynamics

  2. Plasma pyruvate

  3. Plasma glucose

  4. Plasma creatinine

  5. Urinary excretion of alpha-1-microglobulin

  6. Plasma cystatin C

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

  • Deutsche Stiftung für Herzforschung

Registry information

Official study title

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

Acronym: AMORI

Important dates

Study start
2003
Primary completion
2004
Study completion
2007
First posted
Mar 12, 2007
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.