Actively Recruiting
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
Led by Odense University Hospital · Updated on 2025-08-01
254
Participants Needed
1
Research Sites
297 weeks
Total Duration
On this page
Sponsors
O
Odense University Hospital
Lead Sponsor
D
Department of Nephrology, Odense University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- eGFR less than 30 mL/min/1.73 m2
- Scheduled for elective intravenous contrast-enhanced CT scan
- Age 18 years or older
- Signed informed consent to participate
You will not qualify if you...
- Allergy to iodine
- Pregnancy
- Currently receiving dialysis treatment
- Acute infectious or inflammatory disease
- Acute pre- or post-renal kidney failure
- Unable to understand study information
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Cardiology
Odense C, Fyn, Denmark, 5000
Actively Recruiting
Research Team
K
Kristian Altern Øvrehus, Chief physician
CONTACT
E
Emil Johannes Ravn, BSc.Med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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