A randomized trial of saline hydration to prevent contrast nephropathy in chronic renal failure patients.
Bertrand Dussol, Sophie Morange, Anderson Loundoun...
https://pubmed.ncbi.nlm.nih.gov/16611682/Actively Recruiting
Led by Odense University Hospital · Updated on 2025-08-01
254
Participants Needed
1
Research Sites
52 weeks
Total Duration
This research aims to compare intravenous IV hydration and oral hydration to prevent post-contrast acute kidney injury PC-AKI in patients with severe chronic kidney disease CKD who are scheduled for an elective contrast-enhanced CT scan CECT. The study focuses on patients with an estimated glomerular filtration rate eGFR below 30 mLmin1.73 m2, who are at high risk for PC-AKI, a kidney injury that can occur after contrast media use. It also evaluates biomarkers NGAL and cfDNA for early detection and prognosis of PC-AKI and related outcomes. Participants will be randomly assigned to receive either IV hydration with isotonic 0.9% NaCl or oral hydration with bottled water. IV hydration starts three hours before and ends four hours after the CT scan, typically with 1000 mL divided equally before and after the scan patients with heart failure receive a reduced volume of 500 mL. Oral hydration starts one to two hours before and completes within four hours after the scan, with similar volume adjustments. The study is an open-label, randomized controlled trial conducted at Odense University Hospital. During the study, patients will undergo blood and urine tests before, shortly after, and up to 30 days following the CT scan to monitor kidney function, biomarkers, and clinical outcomes including dialysis, hospitalization, and mortality. Follow-ups include medical interviews to assess CKD symptom progression. Patient data is collected via electronic health records and REDCap. Participants may leave the study anytime without consequences. The total follow-up period is 30 days post-CT scan with interim safety analyses planned.
CONDITIONS
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
K
Kristian Altern Øvrehus, Chief physician
E
Emil Johannes Ravn, BSc.Med.
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Odense University Hospital
Lead Sponsor
Department of Nephrology, Odense University Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Eligibility is assessed from electronic health records and laboratory results less than seven days prior to the scheduled IV CECT.
Duration - Within 7 to 14 days before IV CECT
Participants provide verbal and then written informed consent and receive a thorough presentation of the study. Baseline medical history, medication use, echocardiography, blood and urine samples are collected before the scheduled intravenous contrast-enhanced CT scan (IV CECT).
1 visit (in-person) for consent and baseline assessments
Duration - Approximately 7 hours (starting up to 3 hours before IV CECT and completed 4 hours after IV CECT)
Participants receive preventive hydration treatment via either intravenous hydration or oral hydration starting hours before and continuing after the IV CECT procedure, which involves administration of contrast media.
1 visit (in-person) on the day of IV CECT with hydration treatment before and after the scan
Duration - 30 days after IV CECT
Participants are monitored with blood sampling and clinical assessments to evaluate kidney function and detect any adverse events related to the contrast and hydration treatments.
3 to 5 visits (in-person) including visits at 2-3 days, 4-5 days, and 30 days after IV CECT; additional visits may occur if kidney function worsens
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/23727169/Odense University Hospital
Lead Sponsor
Department of Nephrology, Odense University Hospital
Collaborating Sponsor