Topic: Cardiovascular
Conditions
Interventions
Current interventions as of 18/05/2017:
Eligible patients are randomised either to a LG6B leukocyte-depleting filter, or a standard 40µm filter into the arterial line of the extracorpo
Sponsors
Blackpool, Fylde and Wyre Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 18-89 years having single or multiple heart valve repair or replacement as a first time or redo operation as an elective or urgent procedure (i.e. non-emergency procedure), who are able to give informed consent 2. Patients with or without concomitant procedures. Concomitant procedures may include but are not restricted to: coronary artery bypass graft (CABG), ascending aortic and/or root replacement, and ablation for atrial fibrillation 3. Baseline urea and creatinine levels are within normal range, defined as follows: urea 2.5 to 7.8 mmol/L; creatinine 45 to 90 µmol/L for women and 60 to 110 µmol/L for men. Patients taking medications that may influence renal function, such as aspirin, statins, beta adrenergic antagonists, calcium channel antagonists, ACE inhibitors, diuretics and other cardiac medications, can be included provided that baseline urea and creatinine levels are within the normal ranges given above Target Gender: Male & Female; Upper Age Limit 89 years ; Lower Age Limit 18 years
Exclusion criteria
Exclusion criteria: 1. Baseline eGFR <30 ml/min/1.73m2 2. Patients on renal replacement therapy 3. Planned deep hypothermic circulatory arrest with cardiopulmonary bypass switched off 4. Patients participating in any other interventional research study (until the end of the follow-up period of the study). Participation in an observational study will not preclude participation in ROLO
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current outcome measure as of 18/05/2017: The development of AKI is measured using the Kidney Disease: Improving Global Outcomes” (KDIGO) definition of AKI, endorsed in the Renal Association Clinical Guidelines in the period from surgery until 6 weeks after the operation date. Previous primary outcome measure: Primary outcome; Timepoint(s): Development of AKI in the period from surgery until 6 weeks post-op using KDIGO criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 18/05/2017: 1. Proportion of elective patients undergoing elective heart valve eligible for the trial 2. Proportion of eligible patients who agree to participate 3. Tubular kidney injury using the following biomarkers: urinary excretion ratio of Retinol Binding Protein (RBP) to Creatinine (RBP:Cr), urinary excretion ratio of Kidney Injury Molecule-1 to Creatinine (KIM-1:Cr) and urinary NGAL measured at the end of CPB, and at 4, 24, 48 and 72 hours after surgery. RBP:Cr has previously been validated in cardiac surgical patients (16, 17), but recently reviewed evidence suggests that KIM-1:Cr may be a superior biomarker (17, 18). 4. Glomerular kidney injury using the following biomarkers: urinary excretion ratio of Albumin to creatinine (A:Cr) and serum Cystatin C measured at the end of CPB, and at 4, 24, 48 and 72 hours after surgery. These markers, which have potentially better sensitivity compared to glomerular filtration rate(19), allow for early detection of renal injury before conventional clinical parameters, e.g. blood urea and serum creatinine become abnormal 5. Total diuretic dosage over first 5 postoperative days 6. Daily fluid balance (total input and output) over first 5 postoperative days 7. Adverse events including: in-hospital mortality, need for haemodialysis (continuous veno-venous hemofiltration, CVVH) and infection rates in the period from surgery to 12-weeks 8. Length of post-operative stay in hospital (intensive care and ward days) and other resource use in the period from surgery to 12-weeks 9. Health-related Quality of life (HRQoL) assessment: Minnesota Living with Heart Failure Questionnaire (MLHFQ) and EQ-5D measured at baseline, 5 days, 6 and 12 weeks. The MLHFQ27 is recommended as the most responsive validated disease-specific measure for heart failure(20). | — |
Countries
United Kingdom
Outcome results
None listed