Comparing CT scans with and without contrast in patients with kidney issues and acute abdomen
INtravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal functiOn (INCARO) - a Multicentre, Open-label, Randomised Controlled Trial
This study is testing whether using contrast in CT scans is safe for people with kidney problems who have sudden stomach pain compared to scans without contrast.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 994 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 3 sites (Espoo and 2 other locations) |
| Trial ID | NCT04196244 on ClinicalTrials.gov |
What this trial studies
This trial compares the effectiveness and safety of intravenous contrast-enhanced computed tomography (CT) versus native (non-contrast) CT in patients experiencing acute abdominal pain and having impaired renal function. It is a multicenter, open-label, randomized controlled trial that includes patients with an estimated glomerular filtration rate (eGFR) between 15-45 ml/min/1.73 m2. The primary outcome measures all-cause mortality and the need for renal replacement therapy. The goal is to determine if using contrast in these patients poses a significant risk compared to non-contrast imaging.
Who should consider this trial
Good fit: Ideal candidates for this study are adults requiring emergency abdominal or body CT scans with an eGFR between 15-45 ml/min/1.73 m2.
Not a fit: Patients with eGFR below 15 or above 45 ml/min/1.73 m2, those on renal replacement therapy, or those with certain contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer imaging options for patients with impaired renal function, potentially reducing the risk of kidney injury.
How similar studies have performed: While modern retrospective studies suggest no significant risk associated with IV contrast in similar patient populations, this trial is novel as it is the first randomized controlled trial addressing this specific question.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 Exclusion Criteria: * Age less than 18 years * Pregnancy * eGFR less than 15 or more than 45 ml/min/1.73 m2 * Renal replacement therapy within 30 days prior enrolment * CT with IV contrast less than 72 hours prior enrolment * Suspicion of vascular occlusion, dissection or bleeding (i.e. need for IV-contrast) * CT needed without IV-contrast to detect or rule out ureteral stone * IV contrast allergy * Inability to give written consent.
Where this trial is running
Espoo and 2 other locations
- Jorvi hospital, Helsinki University Hospital — Espoo, Finland (Recruiting)
- Meilahti hospital, Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Hyvinkää hospital — Hyvinkää, Finland (Recruiting)
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.