Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

Contrast-induced Nephropathy Clinical Trial

— CINART  

Official title:

Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227835
• Other study ID #: METC 2017-0058
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2019
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1372
• Est. completion date: August 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Contrast-induced Nephropathy
• Kidney Diseases

Intervention

Other:
• intravascular iodinated contrast material administration
Evaluation of the consequences of the protocol change to not giving prophylaxis to patients with an eGFR >29mL/min/1.73m2

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Center	Maastricht	Zuid-Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Centraal BegeleidingsOrgaan (CBO). CBO richtlijnen contrast. 2007 Available from: www.cbo.nl/product/richtlijnen/folder20021023121843/rl_jodium_2007

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of procedures	Number of elective procedures with intravascular contrast in patients formerly eligible for prophylaxis	1 year
Secondary	Contrast-Induced Nephropathy	>25% or >44umol/L increase in serum creatinine from baseline	2-6 days post contrast administration
Secondary	1-month dialysis	incidences of dialysis	26-35 days post-contrast
Secondary	1-month mortality	incidences of all-cause mortality	26-35 days post-contrast