Contrast-induced Nephropathy Clinical Trial
Official title:
Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold
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.
n/a
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