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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Abdomen; Radiocontrast Nephropathy
• Intervention / Treatment: Diagnostic test: Abdominal or body CT with intravenous contrast; Diagnostic test: Abdominal or body CT without intravenous contrast (native CT)

• Study Type: Interventional
• Enrollment (Anticipated): 994
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 00029
    • Recruiting
    • Jorvi Hospital, Helsinki University Hospital
    • Contact: Hanna Lampela, MD, PhD; Phone Number: +35894711; Email: hanna.lampela@hus.fi
  • Helsinki, Finland, 00029
    • Recruiting
    • Meilahti hospital, Helsinki University Hospital
    • Contact: Ville Sallinen, MD, PhD; Phone Number: +35894711; Email: ville.sallinen@hus.fi
  • Hyvinkää, Finland, 00029
    • Recruiting
    • Hyvinkää Hospital
    • Contact: Taina Nykänen, MD, PhD; Phone Number: +35894711; Email: taina.nykanen@hus.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abdominal or body CT with intravenous contrast	Diagnostic test: Abdominal or body CT with intravenous contrast; Abdominal or body CT with intravenous contrast
ACTIVE_COMPARATOR: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute kidney injury (AKI) grade	The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine	Within 72 hours after CT
Any organ failure	Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients)	48 hours after CT
Alive and hospital-free	Alive and hospital-free (days)	Within 90 days after CT
Time from CT to definitive treatment	Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)	During hospital stay estimated on average 7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	6 months from CT
All-cause mortality	All-cause mortality	1 year from CT
All-cause mortality	All-cause mortality	5 years from CT
All-cause mortality	All-cause mortality	10 years from CT
Renal replacement therapy	Number of patients requiring renal replacement therapy	6 months from CT
Renal replacement therapy	Number of patients requiring renal replacement therapy	1 year from CT
Renal replacement therapy	Number of patients requiring renal replacement therapy	5 years from CT
Renal replacement therapy	Number of patients requiring renal replacement therapy	10 years from CT
Renal transplant	Number of patients undegoing renal transplant	6 months from CT
Renal transplant	Number of patients undegoing renal transplant	1 year from CT
Renal transplant	Number of patients undegoing renal transplant	5 years from CT
Renal transplant	Number of patients undegoing renal transplant	10 years from CT

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 18, 2020
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): September 1, 2033

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Renal Insufficiency; Abdomen, Acute
• Other Study ID Numbers: INCARO-HYKS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No