A randomised trial comparing two strategies for preventing kidney failure after angioplasty
| ISRCTN | ISRCTN15027862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15027862 |
| Secondary identifying numbers | 805 |
- Submission date
- 07/05/2009
- Registration date
- 15/07/2009
- Last edited
- 06/08/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Urological and Genital Diseases
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
Dr Periaswamy Vealavan
Scientific
Scientific
Liverpool Heart and Chest Hospital NHS Trust
Thomas Drive
Liverpool
L14 3PE
United Kingdom
| periaswamy.velavan@lhch.nhs.uk |
Study information
| Study design | Randomised controlled open-label trial with 2 x 2 factorial design |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | A randomised factorial trial of N-acetylcysteine prophylaxis and iso-osmolar versus low-osmolar contrast media on kidney function in patients at risk of contrast-induced nephropathy following cardiac catheterisation for percutaneous coronary interventions |
| Study acronym | CONNECT |
| Study objectives | 1. We hypothesise that N-acetylcysteine antioxidant prophylaxis prevents deterioration of renal impairment and may improve survival 2. We also hypothesise that use of iso-osmolar contrast media prevents deterioration of renal function in patients at high risk of contrast-induced nephropathy (CIN) |
| Ethics approval(s) | Submitted via Integrated Research Application System (IRAS) approval pending as of 07/05/2009 |
| Health condition(s) or problem(s) studied | Kidney function impairment/coronary artery disease/contrast-induced nephropathy |
| Intervention | All patients undergoing cardiac catheterisation with the intention of percutaneous coronary intervention (definite PCI or catheterisation +/- PCI) that meet the inclusion criteria will be randomised to receive prophylactic N-acetylcysteine or not, with or without iso- and low-osmolar contrast media. Study arms: Arm 1: iso-osmolar contrast media Arm 2: iso-osmolar contrast media + N-acetylcysteine Arm 3: low-osmolar contrast media Arm 4: low-osmolar contrast media + N-acetylcysteine N-acetylcysteine will be given with a loading dose of 1,200 mg orally prior to the procedure on the day followed by 1,200 mg bulk oral dose for a total of four times (up to 48 hours) after the procedure. Updated 06/08/2014: this trial was stopped before recruitment began in 2011 due to changing practices and procedures, lack of funding and resources and time availability. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine |
| Primary outcome measure | eGFR at 6 months |
| Secondary outcome measures | 1. Contrast-induced nephropathy. Total duration of follow-up: 6 months. 2. eGFR at 14 days 3. Major Adverse Cardiovascular Events (MACE) death, myocardial infarction (MI), stroke, and repeat revascularisation. Total duration of follow-up: 6 months. 4. Renal replacement therapy. Total duration of follow-up: 6 months. |
| Overall study start date | 01/07/2009 |
| Completion date | 30/06/2011 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Male and female patients aged 18 years or over 2. Estimated glomerular filtration rate (eGFR) less than 60 ml/m (as calculated by modified Modification of Diet in Renal Disease [MDRD] equation with local laboratory correction factor) |
| Key exclusion criteria | 1. Patients who had coronary angiography or other procedure with contrast exposure (computed tomography pulmonary angiography [CTPA] etc.) within 2 weeks of percutaneous coronary intervention (PCI) 2. Unable to consent 3. Patient undergoing cardiac surgery 4. Cardiogenic shock 5. Unlikely to attend for follow-up blood tests 6. Presence of non-cardiac illness that might affect life expectancy 7. Any previous allergic reaction to contrast media or N-acetylcysteine (NAC) |
| Date of first enrolment | 01/07/2009 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Liverpool Heart and Chest Hospital NHS Trust
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
| Website | http://www.lhch.nhs.uk |
|---|---|
"ROR" |
https://ror.org/01je02926 |
Funders
Funder type
Hospital/treatment centre
Liverpool Heart and Chest Hospital (UK) - Internal Charitable Trust
No information available
Covidien UK Ltd (UK)
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 |
