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

Study acronym: INCARO
StatusRecruiting
PhasePhase 4
Started
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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.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Nov 2023 to Dec 2023
    • Study completion date: Aug 2033 to Sep 2033
    • Start date changed from estimate of Aug 24, 2020 to Sep 18, 2020
    • Site details revised at 3 of 3 sites
  2. Start date: May 2020 to Aug 24, 2020
    • Primary completion date: Aug 2023 to Nov 2023
    • Study completion date: May 2033 to Aug 2033
    • Eligibility criteria expanded, about 1 word
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04196244
Lead Sponsor Helsinki University Central Hospital
Conditions
(from sponsor)		 Acute Abdomen, Radiocontrast Nephropathy
Related terms Abdomen, Acute
Enrollment 994 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov