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 fractio

• Conditions: I97.1; I25.1; Other functional disturbances following cardiac surgery; Atherosclerotic heart disease

• Registration Number: DRKS00017260
• Lead Sponsor: niversitätsklinikum Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 200

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”)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ow cardiac output syndrome

Secondary Outcome Measures

Name	Time	Method
- Pericardial tamponade<br>- Acute renal failure (RIFLE criteria)<br>- Myocardial ischemia with need for intervention/re-operation<br>- Blood transfusions