Administration of warm blood cardioplegia with or without roller pump; a comparison.

Administration of warm blood cardioplegia with or without roller pump; a comparison. - Pumpless blood cardioplegia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37560

Enrollment

Registered

2012-07-17

Start date

2012-09-18

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CABG coronary artery bypass grafting

Interventions

After informed consent, patients will be randomized into study group (blood cardioplegia administation without roller pump) or control group (blood cardioplegia administration with roller pump).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients undergoing elective coronary artery bypass grafting - At least 3 distal anastomosis will be performed

Exclusion criteria

Exclusion criteria: - Previous cardiac surgery - Left ventricular ejection fraction 177 ug/ml. - Aortic Insufficiency, >= grade 1

Design outcomes

Primary

Measure	Time frame
Perioperative myocardial injury, reflected by biomarker release: - Troponin I - hFABP - NT-pro-BNP	—

Secondary

Measure	Time frame
- Post-operative myocardial infarction: rise of troponin above the 99th percentile together with evidence of myocardial ischaemia (symptoms of ischaemia or ECG changes) - Cardioplegia bloodflow measured with Em-Tec - Pressure in aortic root during blood cardioplegia administration - Line pressure cardioplegia - Total Potassium chloride/Magnesium sulfaat (ml) - Serum potassium level patient after aortic declamping - Longest interval of blood cardioplegia (min) - Mean interval of blood cardioplegia (min) - ECG activity during aortic occlusion - Number of blood cardioplegia gifts - Intra-operative inflammatory respons, refelcted bij CRP level. - Number of anastomosis - ECC time (min) - Aortic occlusion time (min) - Number of defibrillation after aortic declamping - Inotropic support (hours) - Post-operative complications (TIA/CVA, pneumonia, renal failure (createnine>177), re-thoracotomy, atrial fibrillation) - Length of ICU stay - Length of hospital stay	—

Measure

Time frame

- Post-operative myocardial infarction: rise of troponin above the 99th percentile together with evidence of myocardial ischaemia (symptoms of ischaemia or ECG changes) - Cardioplegia bloodflow measured with Em-Tec - Pressure in aortic root during blood cardioplegia administration - Line pressure cardioplegia - Total Potassium chloride/Magnesium sulfaat (ml) - Serum potassium level patient after aortic declamping - Longest interval of blood cardioplegia (min) - Mean interval of blood cardioplegia (min) - ECG activity during aortic occlusion - Number of blood cardioplegia gifts - Intra-operative inflammatory respons, refelcted bij CRP level. - Number of anastomosis - ECC time (min) - Aortic occlusion time (min) - Number of defibrillation after aortic declamping - Inotropic support (hours) - Post-operative complications (TIA/CVA, pneumonia, renal failure (createnine>177), re-thoracotomy, atrial fibrillation) - Length of ICU stay - Length of hospital stay

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)