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RecruitingNCT04196244INCAROUpdated Feb 2, 2021

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

A Phase 4 interventional study of Abdominal or body CT with intravenous contrast and Abdominal or body CT without intravenous contrast (native CT) in Acute Abdomen and Radiocontrast Nephropathy, sponsored by Helsinki University Central Hospital. Recruiting at 3 sites in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-02.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years later.
Phase
Phase 4
Study type
Interventional
Enrollment
994
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Abdomen
  • Radiocontrast Nephropathy
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's planned enrollment of 994 is above the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 299 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
994 participants (estimated)

Study arms

  • Experimental
    Abdominal or body CT with intravenous contrast

    Abdominal or body CT with intravenous contrast

    Diagnostic Test: Abdominal or body CT with intravenous contrast

  • Active comparator
    Abdominal or body CT without intravenous contrast (native CT)

    Abdominal or body CT without intravenous contrast (native CT)

    Diagnostic Test: Abdominal or body CT without intravenous contrast (native 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)

06

What researchers measure

Primary outcomes

  1. Mortality or renal replacement therapy

    A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)

    Time frame: Within 90 days from CT

Secondary outcomes

  1. Acute kidney injury (AKI) grade

    The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine

    Time frame: Within 72 hours after CT

  2. Any organ failure

    Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients)

    Time frame: 48 hours after CT

  3. Alive and hospital-free

    Alive and hospital-free (days)

    Time frame: Within 90 days after CT

  4. Time from CT to definitive treatment

    Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)

    Time frame: During hospital stay estimated on average 7 days

Other outcomes

  1. All-cause mortality

    All-cause mortality

    Time frame: 6 months from CT

  2. All-cause mortality

    All-cause mortality

    Time frame: 1 year from CT

  3. All-cause mortality

    All-cause mortality

    Time frame: 5 years from CT

  4. All-cause mortality

    All-cause mortality

    Time frame: 10 years from CT

  5. Renal replacement therapy

    Number of patients requiring renal replacement therapy

    Time frame: 6 months from CT

  6. Renal replacement therapy

    Number of patients requiring renal replacement therapy

    Time frame: 1 year from CT

  7. Renal replacement therapy

    Number of patients requiring renal replacement therapy

    Time frame: 5 years from CT

  8. Renal replacement therapy

    Number of patients requiring renal replacement therapy

    Time frame: 10 years from CT

  9. Renal transplant

    Number of patients undegoing renal transplant

    Time frame: 6 months from CT

  10. Renal transplant

    Number of patients undegoing renal transplant

    Time frame: 1 year from CT

  11. Renal transplant

    Number of patients undegoing renal transplant

    Time frame: 5 years from CT

  12. Renal transplant

    Number of patients undegoing renal transplant

    Time frame: 10 years from CT

07

Study locations

3 of 3 sites recruiting
  • Jorvi hospital, Helsinki University Hospital
    Espoo, 00029, Finland
    Recruiting
  • Meilahti hospital, Helsinki University Hospital
    Helsinki, 00029, Finland
    Recruiting
  • Hyvinkää hospital
    Hyvinkää, 00029, Finland
    Recruiting
08

References and documents

Publications

  • 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. PubMed 33028554 ↗

Individual participant data

Plan to share: No — Not shared.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04196244
Lead sponsor
Helsinki University Central Hospital
Responsible party
Ville Sallinen (Adj. Prof., Consultant, Clinical researcher, Helsinki University Central Hospital) — Principal investigator
First posted
Dec 12, 2019
Start date
Sep 18, 2020
Primary completion
Dec 2023 (estimated)
Completion
Sep 2033 (estimated)
Last update
Feb 2, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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