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

Primary Purpose

Acute Abdomen, Radiocontrast Nephropathy

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Abdominal or body CT with intravenous contrast
Abdominal or body CT without intravenous contrast (native CT)
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Abdomen

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jorvi hospital, Helsinki University HospitalRecruiting
  • Meilahti hospital, Helsinki University HospitalRecruiting
  • Hyvinkää hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Abdominal or body CT with intravenous contrast

Abdominal or body CT without intravenous contrast (native CT)

Arm Description

Abdominal or body CT with intravenous contrast

Abdominal or body CT without intravenous contrast (native CT)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acute kidney injury (AKI) grade
The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine
Any organ failure
Any organ failure defined by at least 2 SOFA (Sequential Organ Failure Assessment) points excluding central nervous system (number of patients)
Alive and hospital-free
Alive and hospital-free (days)
Time from CT to definitive treatment
Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)

Full Information

First Posted
December 9, 2019
Last Updated
February 1, 2021
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04196244
Brief Title
Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function
Acronym
INCARO
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
September 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Abdomen, Radiocontrast Nephropathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
994 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abdominal or body CT with intravenous contrast
Arm Type
Experimental
Arm Description
Abdominal or body CT with intravenous contrast
Arm Title
Abdominal or body CT without intravenous contrast (native CT)
Arm Type
Active Comparator
Arm Description
Abdominal or body CT without intravenous contrast (native CT)
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal or body CT with intravenous contrast
Intervention Description
Abdominal or body CT with intravenous contrast
Intervention Type
Diagnostic Test
Intervention Name(s)
Abdominal or body CT without intravenous contrast (native CT)
Intervention Description
Abdominal or body CT without intravenous contrast (native CT)
Primary Outcome Measure Information:
Title
Mortality or renal replacement therapy
Description
A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)
Time Frame
Within 90 days from CT
Secondary Outcome Measure Information:
Title
Acute kidney injury (AKI) grade
Description
The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine
Time Frame
Within 72 hours after CT
Title
Any organ failure
Description
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
Title
Alive and hospital-free
Description
Alive and hospital-free (days)
Time Frame
Within 90 days after CT
Title
Time from CT to definitive treatment
Description
Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)
Time Frame
During hospital stay estimated on average 7 days
Other Pre-specified Outcome Measures:
Title
All-cause mortality
Description
All-cause mortality
Time Frame
6 months from CT
Title
All-cause mortality
Description
All-cause mortality
Time Frame
1 year from CT
Title
All-cause mortality
Description
All-cause mortality
Time Frame
5 years from CT
Title
All-cause mortality
Description
All-cause mortality
Time Frame
10 years from CT
Title
Renal replacement therapy
Description
Number of patients requiring renal replacement therapy
Time Frame
6 months from CT
Title
Renal replacement therapy
Description
Number of patients requiring renal replacement therapy
Time Frame
1 year from CT
Title
Renal replacement therapy
Description
Number of patients requiring renal replacement therapy
Time Frame
5 years from CT
Title
Renal replacement therapy
Description
Number of patients requiring renal replacement therapy
Time Frame
10 years from CT
Title
Renal transplant
Description
Number of patients undegoing renal transplant
Time Frame
6 months from CT
Title
Renal transplant
Description
Number of patients undegoing renal transplant
Time Frame
1 year from CT
Title
Renal transplant
Description
Number of patients undegoing renal transplant
Time Frame
5 years from CT
Title
Renal transplant
Description
Number of patients undegoing renal transplant
Time Frame
10 years from CT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Jorvi hospital, Helsinki University Hospital
City
Espoo
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Lampela, MD, PhD
Phone
+35894711
Email
hanna.lampela@hus.fi
Facility Name
Meilahti hospital, Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, MD, PhD
Phone
+35894711
Email
ville.sallinen@hus.fi
Facility Name
Hyvinkää hospital
City
Hyvinkää
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taina Nykänen, MD, PhD
Phone
+35894711
Email
taina.nykanen@hus.fi

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not shared.
Citations:
PubMed Identifier
33028554
Citation
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.
Results Reference
derived

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

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