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Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease

RECRUITINGN/ASponsored by Odense University Hospital
Actively Recruiting
PhaseN/A
SponsorOdense University Hospital
Started2022-04-20
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* eGFR \< 30 mL/min/1.73 m2
* Scheduled for elective IV CECT
* Age ≥ 18
* Signed informed consent

Exclusion Criteria:

* Allergy to Iodine
* Pregnancy
* Active dialysis treatment
* Acute infectious or inflammatory disease
* Acute pre- and/or post-renal kidney failure
* Unable to understand study information

Conditions5

Contrast-induced NephropathyHeart DiseaseKidney Failure, ChronicKidney InjuryRisk Reduction

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