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

Sponsor-declared trial summary

Key facts

Sponsor

University Of Helsinki

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

24 Jun 2025 → ongoing

Decision date (initial)

2025-06-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-512084-31-00

ClinicalTrials.gov

NCT04196244

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To assess superiority of the diagnostic strategy of acute abdomen using intravenous (IV) contrast CT versus native CT in patients with impaired renal function.

Conditions and MedDRA coding

Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2. The eGFR is calculated from the last available plasma creatinine value taken maximum 24 hours before randomisation.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2. The eGFR is calculated from the last available plasma creatinine value taken maximum 24 hours before randomisation.

Exclusion criteria 10

1. Age < 18 years
2. Pregnancy
3. eGFR < 15 or > 45 ml/min/1.73 m2
4. Renal replacement therapy within 30 days
5. CT with IV contrast less than 72 hours ago
6. Suspicion of vascular occlusion or dissection or bleeding (i.e. need for iv contrast)
7. CT needed without iv contrast to detect or rule out ureteral stone
8. IV contrast allergy
9. No signed written informed consent
10. Already randomised in the trial once

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. A composite outcome that combines all-cause mortality or renal replacement therapy within 90 days of contrast medium exposure

Secondary endpoints 4

1. The most severe acute kidney injury (AKI) grade defined by KDIGO classification on plasma creatinine within 72 hours after CT
2. Any organ dysfunction defined by at least 2 mSOFA (modified Sequential Organ Failure Assessment) points excluding central nervous system 48 hours after CT
3. Alive and hospital-free days within 90 days after CT
4. Time from imaging to definitive treatment during hospital stay

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Helsinki

Sponsor organisation

University Of Helsinki

Address

Yliopistonkatu 3

City

Helsinki

Postcode

00100

Country

Finland

Scientific contact point

Organisation

University Of Helsinki

Contact name

corresponding researcher

Public contact point

Organisation

University Of Helsinki

Contact name

Panu Räty

Locations

2 EU/EEA countries · 9 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications