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

ConditionsAcute AbdomenRadiocontrast Nephropathy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abdominal or body CT with intravenous contrast

    Diagnostic test

    Abdominal or body CT with intravenous contrast

  • Abdominal or body CT without intravenous contrast (native CT)

    Diagnostic test

    Abdominal or body CT without intravenous contrast (native CT)

Treatment groups

994 Participants
are divided into 2 treatment groups
Group A: Abdominal or body CT with intravenous contrastExperimental treatment 1 intervention
Group B: Abdominal or body CT without intravenous contrast (native CT)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality 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

Secondary outcomes

1

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
2

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
3

Alive and hospital-free

Alive and hospital-free (days)

Time frame
Within 90 days after CT
4

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

Other outcomes

1

All-cause mortality

All-cause mortality

Time frame
6 months from CT
2

All-cause mortality

All-cause mortality

Time frame
1 year from CT
3

All-cause mortality

All-cause mortality

Time frame
5 years from CT
4

All-cause mortality

All-cause mortality

Time frame
10 years from CT

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

Source ClinicalTrials.gov
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