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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• eGFR \< 30 mL/min/1.73 m2

• Scheduled for elective IV CECT

• Age ≥ 18

• Signed informed consent

Locations
Other Locations
Denmark
Department of Cardiology
RECRUITING
Odense C
Contact Information
Primary
Kristian Altern Øvrehus, Chief physician
kristian.altern.ovrehus@rsyd.dk
+45 28305454
Backup
Emil Johannes Ravn, BSc.Med.
emil.johannes.ravn2@rsyd.dk
+45 31476794
Time Frame
Start Date: 2022-04-20
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 254
Treatments
Other: IV-hydration group (standard of care according to international guidelines)
The IV-hydration with isotonic 0.9% NaCl will be initiated three hours prior to the IV CECT and completed four hours after IV CECT (infusion rate of 1-3 mL/kg/hour). Patients are prescribed a fixed volume of 1000 mL, which is equally distributed before and after IV CECT (500 mL before and 500 mL after).~Patients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is also equally distributed before and after IV CECT (250 mL before and 250 mL after).
Active_comparator: Oral hydration group
The oral hydration regimen will be initiated one-two hours prior to IV CECT and completed within four hours after IV CECT. Patients are prescribed a fixed volume of 1000 mL, which is distributed equally before and after IV CECT (500 mL before and 500 mL after).~Patients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is equally distributed before and after IV CECT (250 mL before and 250 mL after).
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: Region of Southern Denmark, The Research Counsil of Odense University Hospital, The A.P. Moller Foundation, Helen and Ejnar Bjørnow's Foundation, Department of Clinical Genetics, Odense University Hospital, Novo Nordisk A/S, Department of Nephrology, Odense University Hospital, Sophus Jacobsen and Astrid Jacobsen's Foundation, Copenhagen University's Research Foundation for Medical Students

This content was sourced from clinicaltrials.gov