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RecruitingPhase 4NCT04196244

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

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

Sponsor

Helsinki University Central Hospital

Enrollment

994 participants

Start Date

Sep 18, 2020

Study Type

INTERVENTIONAL

Conditions

Acute AbdomenRadiocontrast Nephropathy

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2

Exclusion Criteria9

  • 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.

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Interventions

DIAGNOSTIC_TESTAbdominal or body CT with intravenous contrast

Abdominal or body CT with intravenous contrast

DIAGNOSTIC_TESTAbdominal or body CT without intravenous contrast (native CT)

Abdominal or body CT without intravenous contrast (native CT)

Locations(3)

Jorvi hospital, Helsinki University Hospital

Espoo, Finland

Meilahti hospital, Helsinki University Hospital

Helsinki, Finland

Hyvinkää hospital

Hyvinkää, Finland

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NCT04196244