Clinical Trial

Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function

Study acronym: INCARO
Recruiting Phase 4
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Record status
This record was last updated February 2, 2021 (before its estimated December 2023 completion). Its status may not reflect the trial's current state.
Summary
Computer tomography (CT) is the primary imaging option for acute abdominal pain in adults. Intravenous (IV) contrast media is used to improve the CT quality. In patients with impaired renal function, post-contrast acute kidney injury (PC-AKI) has remained a significant concern. Modern retrospective studies have shown no association between worsened baseline renal function and IV-contrast CT. However, no randomised controlled trial has been done to conclude this. The INCARO (INtravenous Contrast computed tomography versus native computed tomography in patients with acute Abdomen and impaired Renal functiOn) trial is a multicentre, open-label, parallel group, superiority, individually randomised controlled trial comparing IV-contrast enhanced CT to native CT in patients with impaired renal function. Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 are included in the study. The primary outcome is a composite outcome of all-cause mortality or renal replacement therapy within 90 days from CT.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2019-12-11; most recent amendment 2021-02-01.
Status change: Not Yet Recruiting → Recruiting 2021-02-01
Trial Details
NCT Number NCT04196244
Lead Sponsor Helsinki University Central Hospital
Conditions Acute Abdomen, Radiocontrast Nephropathy
Enrollment 994 participants
Start Date 2020-09-18
Primary Completion 2023-12 (estimated)
Study Completion 2033-09 (estimated)
Updated on ClinicalTrials.gov 2021-02-02