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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 Foundation, 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