Pre-operative renal impairment/coronary heart disease/coronary heart interventions Urological and Genital Diseases
Conditions
Interventions
Current information as of 26/03/10:
Eligible patients will be randomised to one of the following groups:
1. Control group: ON-pump high risk cardiac (coronary artery by
Sponsors
Liverpool Heart and Chest Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current information as of 26/03/10: 1. Consenting men and women aged at least 18 years old 2. High-risk patients elective for on-pump valve replacement, coronary artery bypass graft surgery (CABG) or combined CABG and valve procedures 3. Patients with impaired renal function established preoperative by an estimated glomerular filtration rate (eGFR) <50 ml/min Initial information at time of registration: 1. Male and female patients, at least 18 years old 2. Elective for on-pump coronary artery bypass graft surgery (CABG) 3. Patients with impaired renal function established by pre-operative estimated glomerular filtration rate (eGFR) less than 60 ml/min
Exclusion criteria
Exclusion criteria: Current information as of 26/03/10: 1. Patients scheduled to undergoing cardiac surgery with anticipated CPB time 60 or INR >2 without anticoagulation) 4. Patients who are further down the line of renal failure (i.e. eGFR <15 ml/min) 5. Patients on-dialysis 6. Presence of malignancy 7. Pregnancy Initial information at time of registration: 1. Undergoing valve replacement surgery 2. Patients with significant impaired liver function (serum bilirubin greater than 60 or international normalised ratio [INR] greater than 2 without anticoagulation) 3. Patients on-dialysis 4. Patients that are pregnant or have malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 26/03/10: Length of ICU stay for non-dialysis patients with impaired kidney function (estimated glomerular filtration rate <50 ml/min) Initial information at time of registration: Incidents of ICU stay greater than 3 days for patients with eGFR less than 60 ml/min. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 26/03/10: 1. Clinical Outcomes 1.1. Duration of Hospital stay 1.2. Myocardial infarction 1.3. The mean eGFR/creatinine clearance values at hospital discharge 2. Biomarkers Outcomes: 2.1. Plasma levels of protein nitration 2.2. 8-isoprostanes 2.3. Malondialdehyde levels 2.4. Plasma and erythrocyte reduced/oxidised glutathione (GSH/GSSG) ratio 2.5. Urinary N-acetyl-D-glucosamine (D-NAG) excretion 2.6. Highly sensitive C-reactive protein (hsCRP) 2.7. Tumour necrosis factor alpha (TNF-a) Measured at baseline, during CPB, 24 hours and 48 hours after the operation. 3. Secondary Economic Outcomes: Resource utilisation and key costs indicators associated with each of the two pilot arms estimated up until hospital discharge. Specifically: 3.1. ICU stay and hospital stay 3.2. Postoperative renal replacement therapy 3.3. Mechanical ventilation 3.4. Medications Initial information at time of registration: 1. Clinical outcomes: 1.1. Overall length of hospital stay 1.2. Need for renal support post-operatively 1.3. Mechanical ventilation time 1.4. Length of tracheal intubation 1.5. Arrhythmias 1.6. The worst eGFR/creatinine clearance values during hospital stay 1.7. Myocardial infarction 2. Biomarker outcomes: Markers of oxidative stress and the systemic inflammatory response. 3. Cost outcomes: Resource utilisation and costs associated with the intra-operative haemofiltration, care at the ICU and ward and adverse events (e.g., bleeding complications, s | — |
Countries
United Kingdom
Outcome results
None listed