Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT04196244

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

Led by Helsinki University Central Hospital · Updated on 2021-02-02

994

Participants Needed

3

Research Sites

675 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2
Not Eligible

You will not qualify if you...

  • 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 (need for IV-contrast)
  • CT needed without IV-contrast to detect or rule out ureteral stone
  • IV contrast allergy
  • Inability to give written consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Jorvi hospital, Helsinki University Hospital

Espoo, Finland, 00029

Actively Recruiting

2

Meilahti hospital, Helsinki University Hospital

Helsinki, Finland, 00029

Actively Recruiting

3

Hyvinkää hospital

Hyvinkää, Finland, 00029

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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