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

Study Overview
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Brief Summary
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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
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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

Conditions
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Acute Abdomen, Radiocontrast Nephropathy

Intervention / Treatment
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* Diagnostic Test: Abdominal or body CT with intravenous contrast
* Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abdominal or body CT with intravenous contrast<br>Abdominal or body CT with intravenous contrast | Diagnostic Test: Abdominal or body CT with intravenous contrast<br>* Abdominal or body CT with intravenous contrast<br>|
| Active Comparator: Abdominal or body CT without intravenous contrast (native CT)<br>Abdominal or body CT without intravenous contrast (native CT) | Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT)<br>* Abdominal or body CT without intravenous contrast (native CT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality or renal replacement therapy | A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients) | Within 90 days from CT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute kidney injury (AKI) grade | The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine | 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) | 48 hours after CT | 
| Alive and hospital-free | Alive and hospital-free (days) | Within 90 days after CT | 
| Time from CT to definitive treatment | Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication) | During hospital stay estimated on average 7 days |