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

Phase 4

Recruiting

• Conditions: Radiocontrast Nephropathy; Acute Abdomen
• Interventions: Diagnostic Test: Abdominal or body CT with intravenous contrast; Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT)

• Registration Number: NCT04196244
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-11
• Study First Posted: 2019-12-12
• Study Start: 2020-09-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02
• Primary Completion: 2023-12
• Study Completion: 2033-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 994

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abdominal or body CT with intravenous contrast	Abdominal or body CT with intravenous contrast	Abdominal or body CT with intravenous contrast
Abdominal or body CT without intravenous contrast (native CT)	Abdominal or body CT without intravenous contrast (native CT)	Abdominal or body CT without intravenous contrast (native CT)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)
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)

Trial Locations

Locations (3)

Jorvi hospital, Helsinki University Hospital; 🇫🇮 Espoo, Finland

Meilahti hospital, Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Hyvinkää hospital; 🇫🇮 Hyvinkää, Finland