Comparing CT scans with and without contrast in patients with kidney issues and acute abdomen
Official title: 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
Run by Helsinki University Central Hospital · NCT04196244 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 994 (estimated) |
| Sponsor | Helsinki University Central Hospital Academic / other |
| Locations | 3 sites (Espoo and 2 other locations) |
| Status | Recruiting |
| Started | September 18, 2020 |
| Main results expected | December 2023 |
| Study ends | September 2033 |
| Registry record updated | February 2, 2021 |
| Trial ID | NCT04196244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Jorvi hospital, Helsinki University Hospital
Espoo, Finland Recruiting -
Meilahti hospital, Helsinki University Hospital
Helsinki, Finland Recruiting -
Hyvinkää hospital
Hyvinkää, Finland Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.