RecruitingNot ApplicableNCT05283512

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

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


Sponsor

Odense University Hospital

Enrollment

254 participants

Start Date

Apr 20, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of protecting the kidneys before a CT scan with contrast dye in patients who already have severe chronic kidney disease. When contrast dye is injected for imaging, it can further damage already weakened kidneys. This trial tests whether drinking fluids orally works as well as receiving fluids through an IV drip. **You may be eligible if...** - You are 18 or older - You have severe chronic kidney disease (kidney function below 30 mL/min/1.73 m²) - You are scheduled for a planned (elective) contrast-enhanced CT scan **You may NOT be eligible if...** - You have an allergy to iodine (the contrast dye) - You are currently on dialysis - You are pregnant - You have an acute inflammatory or infectious illness - You have acute kidney failure from another cause Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPreventive treatment with IV-hydration

IV hydration with isotonic 0.9% NaCl

OTHERPreventive treatment with oral hydration

Oral hydration with regular bottled water


Locations(1)

Department of Cardiology

Odense C, Fyn, Denmark

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NCT05283512


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