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

NCT04196244 | Recruiting Phase 4

• 1 other identifier: INCARO-HYKS
• Study Type: interventional
• Target: 994
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Abdomen; Radiocontrast Nephropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Acute kidney injury (AKI) grade

  Within 72 hours after CT

• Any organ failure

  48 hours after CT

• Alive and hospital-free

  Within 90 days after CT

• Time from CT to definitive treatment

  During hospital stay estimated on average 7 days

Other Outcomes (12)

• All-cause mortality

  6 months from CT

• All-cause mortality

  1 year from CT

• All-cause mortality

  5 years from CT

Study Arms (2)

Abdominal or body CT with intravenous contrast

EXPERIMENTAL

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)

ACTIVE COMPARATOR

Abdominal or body CT without intravenous contrast (native CT)

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

Interventions

Abdominal or body CT with intravenous contrast 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) DIAGNOSTIC_TEST

Abdominal or body CT without intravenous contrast (native CT)

Abdominal or body CT without intravenous contrast (native CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (3)

Jorvi hospital, Helsinki University Hospital

Espoo, 00029, Finland

RECRUITING

Meilahti hospital, Helsinki University Hospital

Helsinki, 00029, Finland

RECRUITING

Hyvinkää hospital

Hyvinkää, 00029, Finland

RECRUITING

Related Publications (1)

• 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.

  PMID: 33028554 DERIVED

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adj. Prof., Consultant, Clinical researcher

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: September 18, 2020
• Primary Completion: December 1, 2023
• Study Completion (Estimated): September 1, 2033
• Last Updated: February 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)