Outcomes of intraoperative haemofiltration for patients with impaired kidney function undergoing coronary artery bypass graft surgery
| ISRCTN | ISRCTN49513454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49513454 |
| Secondary identifying numbers | HTA 08/53/33; 853 |
- Submission date
- 26/03/2010
- Registration date
- 06/07/2010
- Last edited
- 07/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
It is estimated that up to 20 in 100 patients undergoing cardiac (heart) surgery have a pre-existing kidney impairment that is associated with an increased risk of death during or after the operation. Earlier studies have demonstrated that applying blood filtration (haemofiltration) within the first 48 hours after the operation halves the risk of death. The performance of the procedure two days after surgery may be too late to protect the patient's kidneys from further injury. The aim of this study is to investigate whether haemofiltration performed at the point when the patient is connected to the heart and lung bypass machine during surgery may be more beneficial.
Who can participate?
Patients aged 18 or over, undergoing on-pump coronary artery bypass graft surgery, and who have impaired kidney function.
What does the study involve?
Participants are randomly allocated into two groups. The control group undergo on-pump coronary artery bypass graft surgery without haemofiltration. The intervention group undergo on-pump coronary artery bypass graft surgery with haemofiltration. Participants are followed after the operation to determine their kidney function and length of ICU stay.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Liverpool Heart & Chest Hospital NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2010 to July 2011
Who is funding the study?
Health Technology Assessment Programme (UK)
Who is the main contact?
Dr Bashir Matata
bashir.matata@lhch.nhs.uk
Contact information
Scientific
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| Phone | +44 (0)151 6001380 |
|---|---|
| bashir.matata@lhch.nhs.uk |
Study information
| Study design | Pilot single-blind randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | FOBS (Filtration on Bypass Surgery) |
| Study objectives | 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. More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/085333 Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/53002/PRO-08-53-33.pdf |
| Ethics approval(s) | Liverpool Heart and Chest Hospital, Medical Research Ethics Committee (MREC), 09/06/2010 |
| Health condition(s) or problem(s) studied | Preoperative renal impairment; coronary heart disease; cardiac artery bypass graft surgery |
| Intervention | 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 |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Incidents of ICU stay >3 days for patients with renal impairment identified as an estimated glomerular filtration (eGFR) <60 ml/min |
| Secondary outcome measures | 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 |
| Overall study start date | 01/07/2010 |
| Completion date | 30/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2010 |
| Date of final enrolment | 30/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
L14 3PE
United Kingdom
Sponsor information
Hospital/treatment centre
Thomas Drive
Liverpool
L14 3PE
England
United Kingdom
| Phone | +44 (0)151 2281616 |
|---|---|
| mark.jackson@lhch.nhs.uk | |
| Website | http://www.lhch.nhs.uk |
"ROR" |
https://ror.org/000849h34 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2013 | Yes | No |
Editorial Notes
07/06/2016: Plain English summary added.
