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

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.

Conditions

• Contrast-induced Nephropathy
• Kidney Injury
• Kidney Failure, Chronic
• Risk Reduction

Interventions

OTHER

Preventive treatment with IV-hydration

IV hydration with isotonic 0.9% NaCl

OTHER

Preventive treatment with oral hydration

Oral hydration with regular bottled water

Sponsors & Collaborators

• Department of Nephrology, Odense University Hospital

  collaborator UNKNOWN

• Department of Clinical Genetics, Odense University Hospital

  collaborator UNKNOWN

• The A.P. Moller Foundation

  collaborator UNKNOWN

• The Research Counsil of Odense University Hospital

  collaborator UNKNOWN

• Copenhagen University's Research Foundation for Medical Students

  collaborator UNKNOWN

• Helen and Ejnar Bjørnow's Foundation

  collaborator UNKNOWN

• Novo Nordisk A/S

  collaborator INDUSTRY

• Sophus Jacobsen and Astrid Jacobsen's Foundation

  collaborator UNKNOWN

• Region of Southern Denmark

  collaborator OTHER

• Odense University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-04-20

Primary Completion

2026-12-31

Completion

2027-12-31

Countries

• Denmark

Study Locations