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

Acute Abdomen Clinical Trial

— INCARO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196244
• Other study ID #: INCARO-HYKS
• Status: Recruiting
• Phase: Phase 4
• Start date: September 18, 2020
• Est. completion date: September 2033

Study information

• Verified date: February 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 994
• Est. completion date: September 2033
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Radiocontrast Nephropathy
• Renal Insufficiency

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Finland	Jorvi hospital, Helsinki University Hospital	Espoo
Finland	Meilahti hospital, Helsinki University Hospital	Helsinki
Finland	Hyvinkää hospital	Hyvinkää

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	All-cause mortality	All-cause mortality	6 months from CT
Other	All-cause mortality	All-cause mortality	1 year from CT
Other	All-cause mortality	All-cause mortality	5 years from CT
Other	All-cause mortality	All-cause mortality	10 years from CT
Other	Renal replacement therapy	Number of patients requiring renal replacement therapy	6 months from CT
Other	Renal replacement therapy	Number of patients requiring renal replacement therapy	1 year from CT
Other	Renal replacement therapy	Number of patients requiring renal replacement therapy	5 years from CT
Other	Renal replacement therapy	Number of patients requiring renal replacement therapy	10 years from CT
Other	Renal transplant	Number of patients undegoing renal transplant	6 months from CT
Other	Renal transplant	Number of patients undegoing renal transplant	1 year from CT
Other	Renal transplant	Number of patients undegoing renal transplant	5 years from CT
Other	Renal transplant	Number of patients undegoing renal transplant	10 years from CT
Primary	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	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
Secondary	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
Secondary	Alive and hospital-free	Alive and hospital-free (days)	Within 90 days after CT
Secondary	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