Effect of Remote Ischaemic preConditioning on contrast medium induced nephropathy (CIN) (ERICCIN)
| ISRCTN | ISRCTN49645414 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49645414 |
| Secondary identifying numbers | 14361 |
- Submission date
- 28/06/2013
- Registration date
- 28/06/2013
- Last edited
- 14/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The objective of this study is to investigate whether a new intervention called 'Remote Ischaemic PreConditioning' (RIPC) can reduce the incidence of contrast nephropathy, an acute kidney injury caused by the contrast medium (a substance used to enhance the contrast of structures or fluids within the body in medical imaging) that is used during coronary angiography and angioplasty. It is thought that the contrast medium damages the kidney by reducing kidney blood flow as well as by a direct toxic effect. It is known that an already existing kidney dysfunction is the main pre procedure risk factor for contrast induced kidney injury in addition to a number of other factors such as age over 75, diabetes, anaemia and heart failure. RIPC is a new concept which involves repeated inflation of a blood pressure cuff on the upper arm or leg to cause reduced blood flow and a local oxygen shortage (ischaemia) in the arm or leg tissue. It is thought that the 'ischaemic' tissues release pro survival proteins which also protect other organs in the body from reduced blood flow. Several studies have shown a protective effect in a number of situations including during heart attacks and heart surgery. To date, two small studies have suggested that RIPC can reduce the incidence of contrast nephropathy.
Who can participate?
Male and female patients between the age of 18 and 85, who are awaiting coronary angiography or angioplasty, are able to give informed consent and who have reduced kidney function. The study aims to recruit 360 patients.
What does the study involve?
Patients will be randomly allocated to receive either the 'remote ischaemic preconditioning' treatment or a placebo (dummy). Both groups will then undergo the planned coronary angiogram or angioplasty with the standard measures taken to reduce the risk of an acute kidney injury. Blood and urine tests will be collected prior to and after the procedure to assess whether the treatment has been effective in preventing damage to the patients' kidneys. Patients will be followed up at three months to assess whether there has been any persistent kidney injury or cardiovascular events.
What are the possible benefits and risks of participating?
The benefit of the study will be an increase in the scientific understanding of how RIPC may lead to a reduction in contrast medium induced nephropathy (CIN) and cardiovascular outcomes, as suggested by previous studies. RIPC is known to be a safe intervention with no documented significant adverse effects. Some patients have reported mild discomfort or minor skin bruising at the cuff site during cuff inflation which is temporary.
Where is the study run from?
1. Heart Hospital UCLH (UK)
2. Basildon & Thurrock University Hospital (UK)
3. East Surrey Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2013 to April 2017
Who is funding the study?
The study is being funded by The Hatter Cardiovascular Institute, UCL, as part of a BHF programme grant
Who is the main contact?
Prof. Derek Yellon
d.yellon@ucl.ac.uk
Contact information
Scientific
The Hatter Institute for Cardiovascular Studies
25 Grafton Way
London
WC1E 6DB
United Kingdom
| d.yellon@ucl.ac.uk |
Study information
| Study design | Randomised interventional prevention trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet: Ms Liz Owen, The Hatter Cardiovascular Institute, 67 Chenies Mews, London WC1E 6HX |
| Scientific title | A single-centre double-blinded randomised placebo-controlled study investigating the Effect of Remote Ischaemic preConditioning on Contrast medium Induced Nephropathy in at-risk patients undergoing coronary angiography or PCI (ERICCIN) |
| Study acronym | ERICCIN |
| Study objectives | Remote Ischaemic Preconditioning reduces the incidence of contrast nephropathy in at-risk individuals undergoing coronary angiography or angioplasty. |
| Ethics approval(s) | NRES Committee London - Queen Square, 04/06/2013, ref: 13.LO.0502 |
| Health condition(s) or problem(s) studied | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | Suitable participants awaiting coronary angiography or angioplasty who have impaired kidney function will be stratified into high, medium and low risk groups and then randomly assigned in blocks to receive either the 'remote ischaemic preconditioning' treatment or a placebo. Remote Ischaemic Conditioning, BP cuff inflation on the upper arm to 200mmHg for 5 minutes followed by deflation for 5 minutes. In total four cycles of inflation/deflation administered. Follow Up Length: 3 months Study Entry : Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Contrast Induced Nephropathy; Timepoint(s): Incidence of creatinine elevation by 25% or 0.5g/dl from baseline at 48 hours. |
| Secondary outcome measures | 1. Cardiovascular endpoints; death, MI, revasc, acute heart failure, haemorrhage, rehospitalisation, haemodialysis at 3 months 2. Neutrophil gelatinase-associated lipocalin (NGAL); Timepoint(s): Serum NGAL elevation from baseline at 6 hours post contrast exposure 3. Persistent CIN; Timepoint(s): Incidence of creatinine elevation by 25% / 0.5g/dl from baseline at 3 months post contrast exposure 4. Proteinuria; Timepoint(s): Elevation of dipstick protein and ACR at 48 hours and 3 months following contrast exposure |
| Overall study start date | 01/05/2013 |
| Completion date | 01/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 362; UK Sample Size: 362; Description: Patients awaiting elective or emergency coronary angiography/PCI/CRTD with baseline eGFR (MDRD) <60 ml/min |
| Key inclusion criteria | 1. Age 18 to 85 2. Male or female gender 3. Awaiting coronary angiography or percutaneous coronary intervention, or (added 09/01/2015) CRTD implantation 4. Renal dysfunction with eGFR (MDRD) <60 ml/min/1.73m2 |
| Key exclusion criteria | 1. Age under 18 or over 85 2. Inability to give written informed consent 3. Pregnancy 4. Haemo or peritoneal dialysis patients 5. Contraindication to BP cuff inflation such as significant upper limb peripheral vascular disease 6. Coagulopathy with INR >2.0 7. ST elevation MI/cardiac arrest/cardiogenic shock during admission 8. Participation in another clinical trial within 3 months 9. Intravascular Contrast Exposure within prior 1 month |
| Date of first enrolment | 14/08/2013 |
| Date of final enrolment | 28/10/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
W1G 8PH
United Kingdom
SS16 5NL
United Kingdom
Redhill
RH1 5RH
United Kingdom
Sponsor information
University/education
Gower Street
London
WC1E 6BT
England
United Kingdom
| david.wilson@ucl.ac.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Private sector organisation / Universities (academic only)
- Alternative name(s)
- University College London Hospitals, UCLH
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | The trialists intend to publish the study findings in a high-impact peer reviewed journal shortly. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository at The Hatter Cardiovascular Institute, UCLH. In accordance with its current Records Retention Schedule, research data is retained by UCL as sponsor for 20 years after the research has ended. The UCL Records Office provides a service to UCL staff and maintains records in a safe and secure offsite location and access to stored records is strictly controlled. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/03/2014 | Yes | No | |
| Basic results | 14/05/2018 | 14/05/2018 | No | No |
Additional files
- ISRCTN49645414_BasicResults_14May18.pdf
- Uploaded 14/05/2018
Editorial Notes
14/05/2018: Recruitment dates, publication and dissemination plan, and IPD sharing statement added. The basic results of this trial have been uploaded as an additional file.
09/01/2015: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/12/2014 to 01/03/2017.
2. The trial was changed from a single-centre to a multi-centre trial with the addition of two new participating centres: Basildon & Thurrock University Hospital and East Surrey Hospital.
