Can increased urine flow encouraged by the drug furosemide and increased water intake prevent kidney injury caused by the contrast media used in angiography procedures in patients with reduced kidney function?
| ISRCTN | ISRCTN72194653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72194653 |
- Submission date
- 01/07/2019
- Registration date
- 23/07/2019
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Coronary artery disease (CAD) is common throughout the world and is when the coronary arteries (the blood vessels supplying the heart with oxygen) become blocked or damaged. This can lead to angina (heart pain) and myocardial infarction (heart attack). CAD is caused by the narrowing or blockage of the coronary arteries by fatty deposits and blood clots. CAD can be treated by changing the patient's lifestyle and diet, drugs that open up coronary arteries, or procedures to physically open the arteries. Examples of procedures used are balloon dilatation or stent implantation, where a balloon or wire-mesh tube (stent) attached to a wire is inserted into an artery in the leg or arm and guided into the coronary artery. The balloon can be inflated inside the artery to open it and the stent can be left inside to hold the artery open. The patient can be awake with local pain relief for these procedures. X-rays are used throughout the procedure to see where the blockages are and where the ballooon or stent are. This requires injection of a liquid called contrast medium into the blood to make the blood vessels visible in the X-ray, which is known as angiography. Contrast media are generally safe, but they can cause problems such as acute kidney injury (damage to the kidney), particularly in patients with kidney disease or those who undergo complex procedures requiring multiple treatment sessions or those who need larger amounts of contrast agents. There are different methods used by doctors to decrease the chance acute kidney injury, which have different success rates. Most of these preventive measures involve giving the patient water (hydration) either through the mouth or through a vein. This study will investigate whether matched hydration (giving the patient the same amount of water as they have passed in their urine) alone or combined matched hydration and furosemide is more effective at preventing acute kidney injury. Furosemide is a diuretic drug, which means it increases the production of urine, so matched hydration in the patients receiving furosemide would be expected to involve more water intake.
Who can participate?
Patients with kidney problems who are having a procedure to treat CAD involving contrast media injection.
What does the study involve?
The participants will all have the CAD procedure as normal. They will be randomly allocated to receive matched hydration alone or matched hydration and furosemide. The hydration will start before the injection of contrast media and will continue throughout the procedure and for 4 hours afterwards.
What are the possible benefits and risks of participating?
There might be a reduced risk of CIN. Both groups will be closely monitored for signs of CIN and will be managed with standard treatments if CIN occurs.
Where is the study run from?
University of Sulaimani College of Medicine (Iraq)
When is the study starting and how long is it expected to run for?
November 2017 to December 2019
Who is funding the study?
The researcher is funding the study.
Who is the main contact?
Dr Aram Mirza, aram@arammirza.com
Contact information
Public
Sulaimaniyah
Sulaimaniyah
46001
Iraq
 ORCID ID |
0000-0002-4842-2195 |
|---|---|
| Phone | 009647701570490 |
| aram@arammirza.com |
Scientific
Sulaimaniyah
Sulaimaniyah
46001
Iraq
| ORCID ID |
0000-0002-4842-2195 |
|---|---|
| Phone | 009647701570490 |
| aram@arammirza.com |
Study information
| Study design | Single-center randomized controlled 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 contact details to request a participant information sheet. |
| Scientific title | Contrast-Induced Nephropathy: Evaluation of MAtched hydration and furosemide in risky patients undergoing chronic total occlusion-percutaneous coronary intervention (CINEMA) |
| Study acronym | CINEMA |
| Study hypothesis | Contrast-induced nephropathy (CIN) is the third most common cause for in hospital acute kidney injury. Acute and 1- and 5-year mortality and morbidity (e.g. stroke, myocardial infarction and vessel re-occlusion) incidences are higher in patients who develop CIN as opposed to patients without CIN. Despite the increasing use of pre- and post-procedure hydration protocols and low osmolar instead of high osmolar iodine-containing contrast media, the incidence of CIN is still significant (2-13%), demanding an active role in this area to find a better approach. Our hypothesis is that matched hydration and furosemide is an effective method for prevention of CIN. |
| Ethics approval(s) | Approved 22/01/2018, University of Sulaimani College of Medicine Ethical Committee (c/o Assistant Professor Bakhtiar Mohamed Mahmoud, Department of Medicine, University of Sulaimania School of Medicine, Sulaimania, Kurdistan, Iraq; 009647501540146; bakhtiar.mahmoad@univsul.edu.iq), ref: 60 |
| Condition | Prevention of contrast-induced nephropathy in patients with impaired renal function undergoing percutaneous coronary interventions for chronic total occlusion of the coronary arteries |
| Intervention | After patients have agreed to take part in the study, those with baseline eGFR <60 ml/min/1.73 m2 will be randomly assigned to either control or treatment group. All patients will have a Foley catheter inserted. The treatment group will have a fluid bolus of 250 ml of normal saline (reduced to 150 ml in those with left ventricular [LV] dysfunction) over 30 min and a start dose of furosemide will be administered (0.25-0.5 mg/kg). Injection of contrast medium will be delayed until urine flow rate of >300 ml/h is obtained. The hydration will be continued throughout the duration of the procedure and will last 4 h following the procedure. Urine flow rate is maintained at >300 ml/h with additional doses of furosemide if necessary. The control group will be offered prehydration with sodium chloride 0.9% at 1-1.5 mL/kg/h for 12 h pre-procedure and up to 12 h post-procedure |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Furosemide |
| Primary outcome measure | Contrast-induced acute kidney injury defined as an increase in serum creatinine concentration of 25% or 0.5 mg/dl from the baseline to 48 h after contrast medium exposure |
| Secondary outcome measures | N/A |
| Overall study start date | 01/11/2017 |
| Overall study end date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 998 |
| Participant inclusion criteria | 1. Estimated GFR of <60 mL/min/1.73 m2 2. Receiving contrast media for invasive coronary angiography or intervention |
| Participant exclusion criteria | 1. Aged under 18 years 2. Allergy to furosemide 3. Severe LV dysfunction 4. Receiving dialysis |
| Recruitment start date | 01/01/2018 |
| Recruitment end date | 01/06/2019 |
Locations
Countries of recruitment
- Iraq
Study participating centre
Kurdistan Region
Sulaimaniyah
46001
Iraq
Sponsor information
University/education
Fransoa Miteran Street
Sulaimaniyah
46001
Iraq
| Phone | 009647701510420 |
|---|---|
| abdulsalam.taha@univsul.edu.iq | |
| Website | http://med.univsul.edu.iq/home |
"ROR" |
https://ror.org/00saanr69 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal about one year after overall trial end. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
23/10/2020: The target number of participants was changed from 56 to 998.
10/07/2019: Trial's existence confirmed by the University of Sulaimani College of Medicine Ethical Committee.
