Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

NCT03227835 | Completed

• 1 other identifier: METC 2017-0058
• Study Type: observational
• Target: 1,372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Contrast-induced Nephropathy

Keywords

contrast-induced nephropathy; contrast-induced acute kidney injury; prophylaxis; intravenous hydration

Outcome Measures

Primary Outcomes (1)

• Number of procedures

  Number of elective procedures with intravascular contrast in patients formerly eligible for prophylaxis

  1 year

Secondary Outcomes (3)

• Contrast-Induced Nephropathy

  2-6 days post contrast administration

• 1-month dialysis

  26-35 days post-contrast

• 1-month mortality

  26-35 days post-contrast

Interventions

intravascular iodinated contrast material administration OTHER

Evaluation of the consequences of the protocol change to not giving prophylaxis to patients with an eGFR \>29mL/min/1.73m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at risk of CIN/CIAKI according to the guidelines and an eGFR between 30-59mL/min/1.73m2, who are referred for an elective procedure with intravascular iodinated contrast administration at the MUMC+ after the protocol change i.e. the threshold for prophylactic intravenous hydration has been lowered to eGFR\<30mL/min/1.73m2.

You may qualify if:

• 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.

You may not qualify if:

• eGFR\<30mL/min/1.73m2
• Dialysis/renal replacement therapy
• emergency procedure
• intensive care patient

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Zuid-Limburg, 6202AZ, Netherlands

Location

Related Publications (4)

• 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.

  PMID: 28233565 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32107605 DERIVED

Study Officials

• JE Wildberger

  Maastricht UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 24, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: August 1, 2018
• Last Updated: November 15, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)