- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03227835
Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold (CINART)
After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI, therefore the focus lies on prevention. Clinical practice guidelines for the prevention of CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume expansion with normal saline is recommended as prophylaxis.
Earlier this year the results of the AMACING study (A MAastricht Contrast-Induced Nephropathy Guideline study) were published in The Lancet (NL47173.068.14/METC 14-2-006; Clinical Trials.gov NCT02106234; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These results show that for the greater part (>90%) of patients considered to be at risk of CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard prophylactic hydration confers some risk (5.5% complications of intravenous hydration were recorded in the AMACING study).
As a result the clinical protocol in the Maastricht University Medical Centre (MUMC+) has been adapted, and patients with an estimated Glomerular Filtration Rate (eGFR) >29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after procedures with intravascular iodinated contrast material administration.
CINART is a one year prospective observational study with the aim to evaluate the consequences of the protocol change for 1. for incidences of CIN/CI-AKI, dialysis and mortality, 2. for clinical practice in terms of patient burden (complications of prophylaxis), hospital burden (extra hospitalisations for prophylaxis), and costs, as derived from the number of elective procedures carried out in patients formerly eligible for prophylaxis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Zuid-Limburg
-
Maastricht, Zuid-Limburg, Netherlands, 6202AZ
- Maastricht University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- referred for an elective procedure with intravascular iodinated contrast administration at Maastricht University Medical Centre
- eGFR30-44mL/min/1.73m2 OR eGFR45-59mL/min/1.73m2 + DM OR eGFR45-59mL/min/1.73m2 + >1 risk factor (>age >75 years, anaemia, cardiovascular disease, prescribed NSAID or Diuretic medication) OR multiple myeloma/lymphoplasmacytic lymphoma with small chain proteinuria.
Exclusion Criteria:
- eGFR<30mL/min/1.73m2
- Dialysis/renal replacement therapy
- emergency procedure
- intensive care patient
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of procedures
Time Frame: 1 year
|
Number of elective procedures with intravascular contrast in patients formerly eligible for prophylaxis
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast-Induced Nephropathy
Time Frame: 2-6 days post contrast administration
|
>25% or >44umol/L increase in serum creatinine from baseline
|
2-6 days post contrast administration
|
1-month dialysis
Time Frame: 26-35 days post-contrast
|
incidences of dialysis
|
26-35 days post-contrast
|
1-month mortality
Time Frame: 26-35 days post-contrast
|
incidences of all-cause mortality
|
26-35 days post-contrast
|
Collaborators and Investigators
Investigators
- Principal Investigator: JE Wildberger, Maastricht UMC
Publications and helpful links
General Publications
- Nijssen EC, Rennenberg RJ, Nelemans PJ, Essers BA, Janssen MM, Vermeeren MA, Ommen VV, Wildberger JE. Prophylactic hydration to protect renal function from intravascular iodinated contrast material in patients at high risk of contrast-induced nephropathy (AMACING): a prospective, randomised, phase 3, controlled, open-label, non-inferiority trial. Lancet. 2017 Apr 1;389(10076):1312-1322. doi: 10.1016/S0140-6736(17)30057-0. Epub 2017 Feb 21.
- Centraal BegeleidingsOrgaan (CBO). CBO richtlijnen contrast. 2007 Available from: www.cbo.nl/product/richtlijnen/folder20021023121843/rl_jodium_2007
- Veligheids Management Systeem. VMS veiligheidsprogramma. Voorkomen van nierinsufficiëntie bij intravasculair gebruik van jodiumhoudende contrastmiddelen. September 2009. 2009 [cited; Available from: http:/www.vmszorg.nl/10- Themas/Nierinsufficientie/Praktijkgids-Nierinsufficientie
- Nijssen EC, Nelemans PJ, Rennenberg RJ, van der Molen AJ, van Ommen GV, Wildberger JE. Impact on clinical practice of updated guidelines on iodinated contrast material: CINART. Eur Radiol. 2020 Jul;30(7):4005-4013. doi: 10.1007/s00330-020-06719-7. Epub 2020 Feb 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- METC 2017-0058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Contrast-induced Nephropathy
-
Singapore General HospitalActive, not recruitingContrast-induced NephropathySingapore
-
Chinese PLA General HospitalUnknownContrast-induced NephropathyChina
-
Memorial University of NewfoundlandUniversity of AlbertaWithdrawnContrast Induced NephropathyCanada
-
Sun Yat-sen UniversityCompletedContrast Induced NephropathyChina
-
Isfahan University of Medical SciencesUnknownContrast-Induced NephropathyIran, Islamic Republic of
-
Mt. Sinai Medical Center, MiamiFlorida Heart Research InstituteCompleted
-
Kaiser PermanenteCompletedKidney Diseases | Contrast Induced NephropathyUnited States
-
Ospedale Misericordia e DolceCompletedContrast Induced NephropathyItaly
-
Guangdong Provincial People's HospitalGuangdong Medical College; Hainan People's HospitalUnknownContrast Induced NephropathyChina
-
University of ThessalyUnknownContrast Induced Nephropathy
Clinical Trials on intravascular iodinated contrast material administration
-
Hillel Yaffe Medical CenterUnknown
-
Medical University of South CarolinaCompletedBrain LesionsUnited States
-
I.M. Sechenov First Moscow State Medical UniversityRecruitingCoronary Artery Disease | Angina, Stable | Acute Kidney Injury | Angina, Unstable | Contrast-induced Nephropathy | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial InfarctionRussian Federation
-
I.M. Sechenov First Moscow State Medical UniversityCompletedAcute Kidney Injury | Stable Angina | Contrast-induced Nephropathy
-
University of California, San FranciscoGeneral ElectricCompletedKnown or Suspected Abdominal DiseaseUnited States
-
Wendie BergPA Breast Cancer CoalitionActive, not recruitingBreast CancerUnited States
-
Bracco Diagnostics, IncCompleted
-
M.D. Anderson Cancer CenterRecruitingBreast CarcinomaUnited States
-
Stanford UniversityWithdrawnLiver Transplantation | Renal Insufficiency, Chronic | Acute Kidney Injury | Contrast-induced Nephropathy | Contrast MediaUnited States
-
M.D. Anderson Cancer CenterRecruitingBreast CarcinomaUnited States