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RECRUITING
NCT04196244
PHASE4

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

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

994

Start Date

2020-09-18

Completion Date

2033-09

Last Updated

2021-02-02

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Abdominal or body CT with intravenous contrast

Abdominal or body CT with intravenous contrast

DIAGNOSTIC_TEST

Abdominal 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