Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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