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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
994
Abdominal or body CT with intravenous contrast
Abdominal or body CT without intravenous contrast (native CT)
Jorvi hospital, Helsinki University Hospital
Espoo, Finland
RECRUITINGMeilahti hospital, Helsinki University Hospital
Helsinki, Finland
RECRUITINGHyvinkää hospital
Hyvinkää, Finland
RECRUITINGMortality or renal replacement therapy
A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)
Time frame: Within 90 days from CT
Acute kidney injury (AKI) grade
The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine
Time frame: Within 72 hours after CT
Any organ failure
Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients)
Time frame: 48 hours after CT
Alive and hospital-free
Alive and hospital-free (days)
Time frame: Within 90 days after CT
Time from CT to definitive treatment
Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)
Time frame: During hospital stay estimated on average 7 days
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