NCT05283512 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
| NCT ID | NCT05283512 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Contrast-induced Nephropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 254 participants |
| Start Date | 2022-04-20 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 254 participants in total. It began in 2022-04-20 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05283512 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Contrast-induced Nephropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05283512 currently recruiting?
Yes, NCT05283512 is actively recruiting participants. Contact the research team at kristian.altern.ovrehus@rsyd.dk for enrollment information.
Where is the NCT05283512 trial being conducted?
This trial is being conducted at Odense C, Denmark.
Who is sponsoring the NCT05283512 clinical trial?
NCT05283512 is sponsored by Odense University Hospital. The trial plans to enroll 254 participants.