Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

Study Overview
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Brief Summary
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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.

Official Title
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Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

Conditions
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Contrast-induced Nephropathy

Intervention / Treatment
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* Other: intravascular iodinated contrast material administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures | 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 | >25% or >44umol/L increase in serum creatinine from baseline | 2-6 days post contrast administration | 
| 1-month dialysis | incidences of dialysis | 26-35 days post-contrast | 
| 1-month mortality | incidences of all-cause mortality | 26-35 days post-contrast | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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contrast-induced nephropathy, contrast-induced acute kidney injury, intravenous hydration, prophylaxis