Examining kidney injury risk from iodine contrast in patients with low kidney function
Cohort Study of Intravenous Contrast-media Influence on Decreased Renal Function
This study is trying to see if using iodine contrast during CT scans can harm the kidneys of people with low kidney function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT06171958 on ClinicalTrials.gov |
What this trial studies
This observational study investigates whether the administration of iodine contrast media during computerized tomography (CT) increases the risk of acute kidney injury in patients with significantly reduced renal function (eGFR < 30). It involves collecting blood and urine samples at baseline, three days, and 21 days post-CT to analyze various biomarkers related to kidney health. The study also assesses the decision-making process regarding the use of iodine contrast media and its potential impact on patient care. Conducted at a tertiary university hospital in Sweden, this prospective cohort study aims to provide valuable insights into the safety of contrast media in vulnerable populations.
Who should consider this trial
Good fit: Ideal candidates include adults with an eGFR of less than 30 mL/min/1.73m² who require a CT scan.
Not a fit: Patients under 18 years old, those undergoing renal replacement therapy, or those on nephrotoxic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify safer imaging practices for patients with reduced kidney function, potentially preventing acute kidney injury.
How similar studies have performed: Previous studies have indicated varying risks associated with iodine contrast media in patients with renal impairment, making this investigation relevant but not entirely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * eGFR \<30 mL/min/1.73m2, calculated with the revised Lund-Malmö formula and plasma creatinine. * Medical need of either an ICM-enhanced or unenhanced CT Exclusion Criteria: * \<18 years of age * Ongoing renal replacement therapy * Ongoing treatment with nephrotoxic drugs. Drugs classified as nephrotoxic are acyclovir, aminoglycosides, ciclosporins, cisplatin, methotrexate, non-steroidal anti-inflammatory drugs (except low-dose aspirin) and vancomycin administered intravenously. * Known allergy to ICM who and have not received prophylactic treatment (if patient belongs to ICM arm)
Where this trial is running
Uppsala
- Uppsala University — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Felix B Berglund, MD
- Email: felix.berglund@uu.se
- Phone: +46703387606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.