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Recruiting NCT04196244

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

Phase IV Interventional Acute Abdomen Radiocontrast Nephropathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Abdominal or body CT with intravenous contrast, Abdominal or body CT without intravenous contrast (native CT).
Who it may be relevant to
Registry conditions: Acute Abdomen, Radiocontrast Nephropathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Finland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Diagnostic test Abdominal or body CT with intravenous contrast
    Abdominal or body CT with intravenous contrast
  • Diagnostic test Abdominal or body CT without intravenous contrast (native CT)
    Abdominal or body CT without intravenous contrast (native CT)

Primary outcome measures

  • Mortality or renal replacement therapy [Time frame: Within 90 days from CT]
Secondary outcome measures (4)
  • Acute kidney injury (AKI) grade [Time frame: Within 72 hours after CT]
  • Any organ failure [Time frame: 48 hours after CT]
  • Alive and hospital-free [Time frame: Within 90 days after CT]
  • Time from CT to definitive treatment [Time frame: During hospital stay estimated on average 7 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Finland · 3 centers
  • Jorvi hospital, Helsinki University Hospital — Espoo
  • Meilahti hospital, Helsinki University Hospital — Helsinki
  • Hyvinkää hospital — Hyvinkää

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/bmjope PMID 33028554

Identifiers

NCT: NCT04196244 · INCARO-HYKS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗