The impact of continuous haemofiltration during cardiopulmonary bypass on cardiac surgery patients with impaired renal function
| ISRCTN | ISRCTN48429978 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48429978 |
| Secondary identifying numbers | 704 |
- Submission date
- 07/05/2009
- Registration date
- 15/07/2009
- Last edited
- 04/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Bashir Matata
Scientific
Scientific
Liverpool Heart and Chest Hospital
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| 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 to request a patient information sheet |
| Scientific title | The impact of intra-operative haemofiltration during on-pump cardiac surgery on biomarkers of oxidative stress and healthcare outcomes of patients with impaired renal function: a pilot randomised trial |
| Study acronym | HAEMOTRACKER-TRIAL |
| Study objectives | The application of haemofiltration during cardiopulmonary bypass (CPB) reduces time to tracheal extubation, length of mechanical ventilation and attenuates post-operative anaemia, thrombocytopenia, hypoalbuminemia, post-operative bleeding and post-operative pulmonary complications and this would be the basis for a reduction in intensive care unit (ICU) stay, peri-operative complications and overall length of hospital stay in patients with impaired kidney function undergoing cardiac operations. |
| Ethics approval(s) | Liverpool Heart and Chest Hospital, Medical Reseach Ethics Committee (MREC), 31/12/2009, ref: 09/H1005/71 |
| Health condition(s) or problem(s) studied | Pre-operative renal impairment/coronary heart disease/coronary heart interventions |
| Intervention | 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 bypass graft (CABG) alone, valve surgery, CABG plus valve) surgery patients with GFR <50 ml/min without haemofiltration 2. Experimental group: ON-pump high risk cardiac (coronary artery bypass graft (CABG) alone, valve surgery, CABG plus valve) patients with GFR <50 ml/min undergoing haemofiltration Study timetable: Start of recruitment: April 2010 - Mar 2013 End of follow-up: Apr 2013 Analysis and reporting: May 2013 - Jul 2013 Final report: Sep 2013 Initial information at time of registration: Patients that fulfil inclusion and exclusion criteria will be asked to give consent for the study and will be randomised into the two study groups by a computer-generated programme: 1. ON-pump isolated CABG patients with GFR less than 60 ml/min without haemofiltration (control arm) 2. ON-pump isolated CABG patients with GFR less than 60 ml/min undergoing haemofiltration |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 outcome measures | 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-α) 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, sepsis), requirement for post-operative haemofiltration will be measured. Since the number of operations performed in most cardiac centres depend on availability of ICU beds, the implications for the productivity of the ICU unit will be explored by simulating its activity and resource flows and outcomes, in terms of operations performed per unit time (e.g., a year). Patients will be followed-up for all secondary outcome measures until the time of hospital discharge. |
| Overall study start date | 01/08/2009 |
| Completion date | 01/09/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 196 (as of 26/03/2010; previous sample size: 60) |
| Total final enrolment | 199 |
| Key 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 |
| Key exclusion criteria | Current information as of 26/03/10: 1. Patients scheduled to undergoing cardiac surgery with anticipated CPB time <60 minutes 2. Patients undergoing surgery on the great vessels (aortic surgery) 3. Patients with significant impaired liver function (serum bilirubin > 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/03/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Heart and Chest Hospital
Liverpool
L14 3PE
United Kingdom
L14 3PE
United Kingdom
Sponsor information
Liverpool Heart and Chest Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Thomas Drive
Liverpool
L14 3PE
England
United Kingdom
| mark.jackson@lhch.nhs.uk | |
| Website | http://www.lhch.nhs.uk |
"ROR" |
https://ror.org/01je02926 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - DH CSO Healthcare Scientist Research Fellowship
No information available
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? |
|---|---|---|---|---|---|
| Other publications | post-hoc analysis of biomarker levels | 01/10/2019 | 04/11/2019 | Yes | No |
| Results article | results | 01/10/2015 | 04/11/2019 | Yes | No |
Editorial Notes
04/11/2019: The following changes were made:
1. Publication reference added.
2. The final enrolment number was added from the reference.
02/10/2017: No publications found, verifying study status with principal investigator.
