The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL/min/1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR \< 30 mL/min/1.73 m2).
Thus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration.
Our research hypotheses consist of the following:
1. Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT. 2. NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.
eGFR < 30 mL/min/1.73 m2
Scheduled for elective IV CECT
Age ≥ 18
Signed informed consent
Allergy to Iodine
Pregnancy
Active dialysis treatment
Acute infectious or inflammatory disease
Parallel
Preventive treatment with IV-hydration
Other interventionIV hydration with isotonic 0.9% NaCl
Preventive treatment with oral hydration
Other interventionOral hydration with regular bottled water
Incidence of PC-AKI
The incidence of PC-AKI within the two arms
Incidence of new onset need for dialysis treatment
The incidence of patients with incident need for dialysis treatment, which is registered from the EHR and/or telephone consultation
Renal adverse events
The incidence of renal adverse events defined as a relative increase in SCr \> 15% and/or a decrease in eGFR \> 15% and/or progression in CKD-stage from CKD-stage IV to CKD-stage Va
Hospitalization due to symptomatic heart failure
The incidence of patients hospitalized due to symptomatic heart failure, which is registered from the EHR and/or telephone consultation
All-cause mortality
All-cause mortality, which is registered from the EHR
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Odense University Hospital
Lead sponsor
Department of Nephrology, Odense University Hospital
Collaborator
Department of Clinical Genetics, Odense University Hospital
Collaborator
The A.P. Moller Foundation
Collaborator
The Research Counsil of Odense University Hospital
Collaborator
Copenhagen University's Research Foundation for Medical Students
Collaborator
Helen and Ejnar Bjørnow's Foundation
Collaborator
Novo Nordisk A/S
Collaborator
Sophus Jacobsen and Astrid Jacobsen's Foundation
Collaborator
Region of Southern Denmark
Collaborator
