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NCT Number: NCT04196244

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

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.

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Key information

Conditions

Acute Abdomen Abdomen, Acute Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Radiocontrast Nephropathy Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jorvi hospital, Helsinki University Hospital, Espoo, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abdominal or body CT with intravenous contrast

Diagnostic Test

Abdominal or body CT with intravenous contrast

Abdominal or body CT without intravenous contrast (native CT)

Diagnostic Test

Abdominal or body CT without intravenous contrast (native CT)

Primary outcomes

  1. Mortality or renal replacement therapy

    Time frame: Within 90 days from CT

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

Secondary outcomes

  1. Acute kidney injury (AKI) grade

    Time frame: Within 72 hours after CT

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

  2. Any organ failure

    Time frame: 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)

  3. Alive and hospital-free

    Time frame: Within 90 days after CT

    Alive and hospital-free (days)

  4. Time from CT to definitive treatment

    Time frame: During hospital stay estimated on average 7 days

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

Other outcomes

  1. All-cause mortality

    Time frame: 6 months from CT

    All-cause mortality

  2. All-cause mortality

    Time frame: 1 year from CT

    All-cause mortality

  3. All-cause mortality

    Time frame: 5 years from CT

    All-cause mortality

  4. All-cause mortality

    Time frame: 10 years from CT

    All-cause mortality

  5. Renal replacement therapy

    Time frame: 6 months from CT

    Number of patients requiring renal replacement therapy

  6. Renal replacement therapy

    Time frame: 1 year from CT

    Number of patients requiring renal replacement therapy

  7. Renal replacement therapy

    Time frame: 5 years from CT

    Number of patients requiring renal replacement therapy

  8. Renal replacement therapy

    Time frame: 10 years from CT

    Number of patients requiring renal replacement therapy

  9. Renal transplant

    Time frame: 6 months from CT

    Number of patients undegoing renal transplant

  10. Renal transplant

    Time frame: 1 year from CT

    Number of patients undegoing renal transplant

  11. Renal transplant

    Time frame: 5 years from CT

    Number of patients undegoing renal transplant

  12. Renal transplant

    Time frame: 10 years from CT

    Number of patients undegoing renal transplant

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study 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

Acronym: INCARO

Important dates

Study start
2020
Primary completion
2023
Study completion
2033
First posted
Dec 12, 2019
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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