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

Recruiting now · Phase 4

Conditions studied: Acute Abdomen, Radiocontrast Nephropathy

In brief

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.

Key facts

Study ID

NCT04196244

Run by

Helsinki University Central Hospital

People needed

994

Starts

2020-09-18

Expected to finish

2033-09-01

Last updated by the study team

2021-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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 is running

• Jorvi hospital, Helsinki University Hospital — Espoo, Finland (enrolling)
• Meilahti hospital, Helsinki University Hospital — Helsinki, Finland (enrolling)
• Hyvinkää hospital — Hyvinkää, Finland (enrolling)

Full record on ClinicalTrials.gov

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