Fat Filtration and Organ Injury following Cardiac Surgery
| ISRCTN | ISRCTN56462370 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56462370 |
| Secondary identifying numbers | REM09 |
- Submission date
- 24/08/2010
- Registration date
- 20/09/2010
- Last edited
- 04/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Richard Issitt
Scientific
Scientific
Perfusion Department, Level 1 Theatres
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| richardissitt@btinternet.com |
Study information
| Study design | Single-centre blind randomised controlled 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 contact details below to request a patient information sheet |
| Scientific title | Quantification of lipid and leukocyte filtration and the effects on cerebral and renal injury markers and pulmonary function during cardiopulmonary bypass. |
| Study objectives | The hypothesis being tested is that the filtration of lipid emboli and activated leucocytes from the blood will result in lower levels of organ injury as seen by biochemical marker analysis. |
| Ethics approval(s) | The Oxford Research Ethics Committee C, 25/06/2009, ref: 10/H0606/30 |
| Health condition(s) or problem(s) studied | Cardiopulmonary bypass |
| Intervention | Use of the RemoweLL Oxygenator containing a lipid and leucocyte depleting filter against current standard oxygenator during cardiopulmonary bypass for patients undergoing coronary artery bypass grafting. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Concentration of lipid microemboli measured using light microscopy and Oil Red O staining before and after cardiopulmonary bypass compared to control 2. Percentage of activated leucocytes using flow cytometry marker CD11b before and after cardiopulmonary bypass compared to control |
| Secondary outcome measures | Levels of biochemical markers of organ injury, specifically 1. Brain (neuron-specific enolase [NSE]) 2. Kidneys (Cystatin C and standard laboratory tests) and 3. Pulmonary function as measured by calculation of the respiratory index Comparison between before and after results with trial and standard oxygenator. |
| Overall study start date | 06/09/2010 |
| Completion date | 06/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 patients, 25 in each group |
| Key inclusion criteria | 1. Participant is willing and able to give informed consent for participation in the study - any documented history of cognitive impairment will exclude the patient as this may have an effect on biochemical markers of cerebral injury 2. Male or female, aged 18 years or above 3. Patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery 4. Angiographically proven coronary artery stenosis |
| Key exclusion criteria | 1. Age less than 18 or more than 90 years old 2. Emergency CABG surgery 3. Previous CABG surgery 4. Gross haemodynamic instability: 4.1. Hypertension (systolic blood pressure >160mmHg) 4.2. Hypotension (systolic blood pressure <90mmHg) 4.3. Bradycardia (heart rate <60 beats/min) 5. Diabetes 6. Obesity (BMI >30) 7. Pre-operative heparin regime 8. Abnormal preoperative white cell count (<4 or >10x109 cells/L) 9. Renal failure (serum creatinine >150µmol/L) |
| Date of first enrolment | 06/09/2010 |
| Date of final enrolment | 06/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Eurosets s.r.l. (Italy)
Industry
Industry
Strada Statale 12
n°143
Medolla
41036
Italy
"ROR" |
https://ror.org/02pqj5664 |
|---|
Funders
Funder type
Industry
Eurosets s.r.l. (Italy)
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? |
|---|---|---|---|---|---|
| Protocol article | results | 02/02/2016 | Yes | No |
Editorial Notes
04/10/2017: Publication reference added.
