Acute Abdomen, Radiocontrast Nephropathy
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTAbdominal or body CT with intravenous contrast
Abdominal or body CT with intravenous contrast
DIAGNOSTIC_TESTAbdominal or body CT without intravenous contrast (native CT)
Abdominal or body CT without intravenous contrast (native CT)
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality or renal replacement therapy | Within 90 days from CT | A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any organ failure | 48 hours after CT | Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients) |
| Acute kidney injury (AKI) grade | Within 72 hours after CT | The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine |
| Alive and hospital-free | Within 90 days after CT | Alive and hospital-free (days) |
| Time from CT to definitive treatment | During hospital stay estimated on average 7 days | Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Renal transplant | 6 months from CT | Number of patients undegoing renal transplant |
| Renal replacement therapy | 6 months from CT | Number of patients requiring renal replacement therapy |
| All-cause mortality | 6 months from CT | All-cause mortality |
Countries
Finland
Outcome results
None listed