Comparing IV and oral hydration to prevent kidney injury after CT scans in severe kidney disease patients
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 (ENRICH): A Randomized Controlled Trial
This study is testing whether drinking fluids can be just as good as getting IV fluids to help prevent kidney injury in patients with severe kidney disease who are having a CT scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 254 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Locations | 1 site (Odense C, Fyn) |
| Trial ID | NCT05283512 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of intravenous (IV) hydration versus oral hydration in preventing post-contrast acute kidney injury (PC-AKI) in patients with severe chronic kidney disease (CKD) scheduled for elective contrast-enhanced computed tomography (CECT). It is a pragmatic, single-centre, open-label, parallel-group non-inferiority randomized controlled trial conducted at Odense University Hospital. Participants will be randomly assigned to receive either IV hydration or oral hydration before and after the CECT procedure. The study aims to determine if oral hydration can be as effective as the standard IV hydration protocol recommended for high-risk patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an eGFR less than 30 mL/min/1.73 m2 who are scheduled for elective IV CECT.
Not a fit: Patients currently undergoing active dialysis treatment or those with acute kidney failure or severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more convenient hydration method for patients with severe chronic kidney disease undergoing CT scans.
How similar studies have performed: Previous studies have shown that oral hydration is non-inferior to IV hydration in patients with mild to moderate CKD, but this specific approach in severe CKD is novel and untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Odense C, Fyn
- Department of Cardiology — Odense C, Fyn, Denmark (Recruiting)
Study contacts
- Study coordinator: Kristian Altern Øvrehus, Chief physician
- Email: kristian.altern.ovrehus@rsyd.dk
- Phone: +45 28305454
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.