Clinical trial NCT04196244: Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Acute Abdomen
Radiocontrast Nephropathy
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality or renal replacement therapy
timeFrame: Within 90 days from CT
Secondary outcomes:
measure: Acute kidney injury (AKI) grade
timeFrame: Within 72 hours after CT
measure: Any organ failure
timeFrame: 48 hours after CT
measure: Alive and hospital-free
timeFrame: Within 90 days after CT
measure: Time from CT to definitive treatment
timeFrame: During hospital stay estimated on average 7 days
Other outcomes:
measure: All-cause mortality
timeFrame: 6 months from CT
measure: All-cause mortality
timeFrame: 1 year from CT
measure: All-cause mortality
timeFrame: 5 years from CT
measure: All-cause mortality
timeFrame: 10 years from CT
measure: Renal replacement therapy
timeFrame: 6 months from CT
measure: Renal replacement therapy
timeFrame: 1 year from CT
measure: Renal replacement therapy
timeFrame: 5 years from CT
measure: Renal replacement therapy
timeFrame: 10 years from CT
measure: Renal transplant
timeFrame: 6 months from CT
measure: Renal transplant
timeFrame: 1 year from CT
measure: Renal transplant
timeFrame: 5 years from CT
measure: Renal transplant
timeFrame: 10 years from CT
Locations:
city: Espoo
country: Finland
facility: Jorvi hospital, Helsinki University Hospital
city: Helsinki
country: Finland
facility: Meilahti hospital, Helsinki University Hospital
city: Hyvinkää
country: Finland
facility: Hyvinkää hospital
Study officials:
References:
citation: Raty P, Mentula P, Lampela H, Nykanen T, Helantera I, Haapio M, Lehtimaki T, Skrifvars MB, Vaara ST, Leppaniemi A, Sallinen V. 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 - study protocol. BMJ Open. 2020 Oct 6;10(10):e037928. doi: 10.1136/bmjopen-2020-037928.