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Clinical Trials/DRKS00017260
DRKS00017260
Not yet recruiting
Not Applicable

Post-operative cerebral oximetry for detection of low-cardiac output syndrome after coronary artery bypass surgery in patients with low pre-operative left ventricular ejection fraction

niversitätsklinikum Bonn0 sites200 target enrollmentSeptember 6, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
I97.1
Sponsor
niversitätsklinikum Bonn
Enrollment
200
Status
Not yet recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2019
End Date
TBD
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
niversitätsklinikum Bonn

Eligibility Criteria

Inclusion Criteria

  • 1\. Patients \=18 years undergoing isolated, on\-pump coronary artery bypass grafting
  • 2\. The surgery is elective or urgent (either planned or within one hospital admission between diagnosis and treatment), can be for STEMI/NSTEMI/ACS
  • 3\. Pre\-operative Left ventricular function is \<30% as measured by left ventricular
  • angiography or transthoracic echocardiography by simpson biplane method
  • 4\. The patient gives written informed consent to take part in the study
  • 5\. The patient is hemodynamically stable upon admission to ICU (max. dose epinephrine \=0\.05µg/kg/min, dobutamine \=3µg/kg/min, enoximone/milrinone \=2µg/kg/min, Noradrenaline \=0\.2µg/kg/min)
  • 6\. No metabolic acidosis is present on admission to ICU (Base excess \= \-10, pH \>7\.30\)
  • 7\. The patient is normotensive on admission to ICU (Mean arterial pressure \=60mmHg)
  • 8\. Upon admission to ICU, Cardiac index is \=80% of the pre\-operative value

Exclusion Criteria

  • 1\. Manifest LCOS (see definition in primary endpoint section) upon admission to ICU
  • 2\. Central Venous Pressure \=20mmHg on admission to ICU
  • 3\. Coronary artery bypass grafting was combined with other procedure (i.e. valve surgery)
  • 4\. Cardiac arrest with external cardiopulmonal resuscitation prior to admission to ICU
  • 5\. Patient is on extracorporal life\-support or has an intra\-aortic ballon pump (IABP) upon admission to ICU
  • 6\. Procedure was performed as salvage procedure (i.e. with cardiopulmonary rescucitation prior to initiating cardiopulmonary bypass, patient was unstable upon transfer to operating theatre sliding on inotropes”)

Outcomes

Primary Outcomes

Not specified

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