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| [ ...Back to search results ] | [ Print-friendly version ] |
| Outcomes of intraoperative haemofiltration for patients with impaired kidney function undergoing coronary artery bypass graft surgery |
| ISRCTN | ISRCTN49513454 |
| ClinicalTrials.gov identifier | |
| Public title | Outcomes of intraoperative haemofiltration for patients with impaired kidney function undergoing coronary artery bypass graft surgery |
| Scientific title | The impact of continuous haemofiltration with high volume fluid exchange during cardiopulmonary bypass surgery on the recovery of patients with impaired renal function- a pilot study |
| Acronym | FOBS (Filtration on Bypass Surgery) |
| Serial number at source | HTA 08/53/33; 853 |
| Study hypothesis | We hypothesise that intraoperative haemofiltration significantly reduces incidences of intensive care unit stay longer than 3 days for patient with preoperative impaired kidney undergoing coronary artery bypass graft surgery |
| Lay summary | |
| Ethics approval | Liverpool Heart and Chest Hospital, Medical Reseach Ethics Committee (MREC) approved on the 9th of June 2010 |
| Study design | Pilot single blind randomised controlled single centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Preoperative renal impairment; coronary heart disease; cardiac artery bypass graft surgery |
| Participants - inclusion criteria |
1. Consenting men and women must be at least 18 years old
2. High-risk patients elective for on-pump coronary artery bypass graft surgery (CABG) 3. Impaired renal function established preoperatively by an estimated glomerular filtration rate (eGFR) <60 ml/min measured within 4 weeks before surgery |
| Participants - exclusion criteria |
1. Patients undergoing surgery on the great vessels (aortic surgery)
2. Patients with significantly impaired liver function (serum bilirubin> 60 or INR>2 without anticoagulation) 3. Patients who are further down the line of renal failure or on-dialysis 4. Patients with malignancy 5. Those that are pregnant |
| Anticipated start date | 01/07/2010 |
| Anticipated end date | 30/07/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 60 |
| Interventions |
Patients that fulfil inclusion and exclusion criteria will be fully informed about the study and asked to give consent for the study. They will be randomised into two study groups by a computer-generated programme:
1. Control group: Patients with estimated GFR <60 ml/min undergoing ON-pump coronary artery bypass graft surgery without intraoperative haemofiltration 2. Intervention group: Patients with estimated GFR <60 ml/min undergoing ON-pump coronary artery bypass graft surgery with intraoperative haemofiltration |
| Primary outcome measure(s) | Incidents of ICU stay >3 days for patients with renal impairment identified as an estimated glomerular filtration (eGFR) <60 ml/min |
| Secondary outcome measure(s) |
1. Clinical outcomes:
1.1. Composite of perioperative incidences: 1.1.1. Bleeding 1.1.2. Sepsis 1.1.3. Death 1.1.4. Arrhythmias 1.1.5. Stroke 1.1.6. Myocardial infarction 1.2. Need for postoperative continuous veno-venous haemofiltration (CVVH) in the ICU and wards - Indications for requirement of postoperative continuous veno-venous haemofiltration must adhere to our strict NHS Trust criteria and guidelines. 1.3. Mechanical ventilation time 1.4. Hospital stay 1.5. eGFR at 6 weeks follow-up 2. Economic outcomes: Resource utilisation and costs associated with each of the two pilot arms such as: 2.1. ICU stay and hospital stay 2.2. Mechanical ventilation 2.3. Medications 2.4. Tests and procedures undertaken until the end of the follow-up period |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) |
| Trial website | |
| Publications | |
| Contact name | Dr Bashir Matata |
| Address | Thomas Drive |
| City/town | Liverpool |
| Zip/Postcode | L14 3PE |
| Country | United Kingdom |
| Tel | +44 (0)151 6001380 |
| Fax | +44 (0)151 6001647 |
| bashir.matata@lhch.nhs.uk | |
| Sponsor | Liverpool Heart & Chest Hospital NHS Foundation Trust (UK) |
| Address | Thomas Drive |
| City/town | Liverpool |
| Zip/Postcode | L14 3PE |
| Country | United Kingdom |
| Tel | +44 (0)151 2281616 |
| Fax | +44 (0)151 6001646 |
| mark.jackson@lhch.nhs.uk | |
| Sponsor website: | http://www.lhch.nhs.uk |
| Date applied | 26/03/2010 |
| Last edited | 06/07/2010 |
| Date ISRCTN assigned | 06/07/2010 |
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