Clinical Trials Logo
  1. Home
  2. Cardiac Output, Low
  3. NCT00446017
  4. Details
NCT00446017 Clinical Trial

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

Cardiac Output, Low Clinical Trial

— AMORI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00446017
Other study ID # HL-ANAE-101
Secondary ID
Status Completed
Phase Phase 3
First received March 9, 2007
Last updated June 2, 2015
Start date June 2003
Est. completion date April 2007

Study information
Verified date April 2007
Source University of Luebeck
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 2007
Est. primary completion date August 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• adrenaline

• milrinone

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
University of Luebeck Deutsche Stiftung für Herzforschung

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma lactate concentration in the immediate postoperative period
Secondary Hemodynamics
Secondary Plasma pyruvate
Secondary Plasma glucose
Secondary Plasma creatinine
Secondary Urinary excretion of alpha-1-microglobulin
Secondary Plasma cystatin C
See also
  Status Clinical Trial Phase
Completed NCT05070819 - Atrial Natriuretic Peptide in Assessing Fluid Status N/A
Recruiting NCT05492968 - The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance Phase 4
Completed NCT03444545 - Continous Cardiac Output - Non-Invasive Evaluation (CONNIE)
Recruiting NCT04064177 - Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Withdrawn NCT03058653 - Use of a Mini-fluid Bolus to Identify Fluid Responsiveness N/A
Completed NCT02880683 - Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study N/A
Recruiting NCT00989508 - Myocardial Protection With Perhexiline in Left Ventricular Hypertrophy Phase 2/Phase 3
Completed NCT04955184 - Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter
Completed NCT02964663 - Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery N/A
Completed NCT04641949 - Methoxyflurane and Fentanyl in LBNP Phase 4
Recruiting NCT04191408 - Predictive Ability of PEEP Induced Changes in CVP to Predict Volume Responsiveness in Mechanically Ventilated Patients After Major Abdominal Surgery N/A
Completed NCT01892696 - Effects of Inspiratory Flow Waveforms on Preload N/A
Recruiting NCT02728791 - Comparison of Allows Measurement of Cardiac Output Between Clearsight System and Transpulmonary Thermodilution N/A
Completed NCT03930979 - The Effect of Hyperoxia on Cardiac Output
Recruiting NCT04755764 - Effect of Labetalol, Atenolol, and Nifedipine on Maternal Hemodynamics Measured by ICG in Early Pregnancy
Enrolling by invitation NCT02702544 - Effect of Passive Leg Raising for Fluid Responsiveness N/A
Completed NCT01880684 - Validation of Capnography as a Predictor of Cardiac Output Change as Measured by FloTrac Phase 2
Recruiting NCT05035719 - Comparison Studies Comparing Hemodynamic Parameters Provided by the Caretaker Against Respective Gold Standard References
Not yet recruiting NCT04774978 - Real-time Continuous Cardiac Output Measurements N/A
Completed NCT02485782 - Changes in Volumetric Hemodynamic Parameters Induced by Fluid Removal on Hemodialysis N/A