Acute AbdomenPhase 4INCARONCT04196244
Intravenous Contrast Computed Tomography Versus Native Computed Tomography in Patients With Acute Abdomen and Impaired Renal Function
A Phase 4 study testing Abdominal or body CT with intravenous contrast and Abdominal or body CT without intravenous contrast (native CT) in people with Acute Abdomen and Radiocontrast Nephropathy, run by Helsinki University Central Hospital at 3 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen, Radiocontrast Nephropathy
- What is being tested?
- Abdominal or body CT with intravenous contrast and Abdominal or body CT without intravenous contrast (native CT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- 3 sitesFinland
- Study dates
- 18 Sep 2020to Sep 2033
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2
Who cannot join
- 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)
Show all 9Show fewer
- CT needed without IV-contrast to detect or rule out ureteral stone
- IV contrast allergy
- Inability to give written consent.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland3 sites, 3 recruiting
- Recruiting
Jorvi hospital, Helsinki University Hospital
Espoo, 00029
Hanna Lampela, MD, PhD, +35894711, hanna.lampela@hus.fi
- Recruiting
Meilahti hospital, Helsinki University Hospital
Helsinki, 00029
Ville Sallinen, MD, PhD, +35894711, ville.sallinen@hus.fi
- Recruiting
Hyvinkää hospital
Hyvinkää, 00029
Taina Nykänen, MD, PhD, +35894711, taina.nykanen@hus.fi
About this study
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
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
- Being tested
- Abdominal or body CT with intravenous contrast, Abdominal or body CT without intravenous contrast (native CT)
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal or body CT with intravenous contrastDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| Abdominal or body CT with intravenous contrast | Experimental | Abdominal or body CT with intravenous contrast Receives: 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) Receives: Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or renal replacement therapy
A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)
Measured: Within 90 days from CT
Secondary outcomes (4)
Acute kidney injury (AKI) grade
The most severe acute kidney injury (AKI) grade defined by KDIGO classification on serum creatinine
Measured: 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)
Measured: 48 hours after CT
Alive and hospital-free
Alive and hospital-free (days)
Measured: Within 90 days after CT
Time from CT to definitive treatment
Time from CT to definitive treatment (i.e. surgery, radiological intervention, endoscopy, medication)
Measured: During hospital stay estimated on average 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start18 Sep 2020
- Primary completionDec 2023 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 994 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ville Sallinen, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196244
- Sponsor's protocol ID
- INCARO-HYKS
- Acronym
- INCARO
- Status last verified
- Feb 2021
- First submitted
- 9 Dec 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not shared.
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.
PubMed 33028554
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04196244
- Acronym / sponsor ID
- INCARO / INCARO-HYKS
- Conditions
- Acute Abdomen, Radiocontrast Nephropathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 994 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Sep 2033 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal or body CT with intravenous contrast | Experimental | Diagnostic Test: Abdominal or body CT with intravenous contrastAbdominal or body CT with intravenous contrast |
| Abdominal or body CT without intravenous contrast (native CT) | Active comparator | Diagnostic Test: Abdominal or body CT without intravenous contrast (native CT)Abdominal or body CT without intravenous contrast (native CT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring emergency abdominal or body CT with eGFR 15-45 ml/min/1.73 m2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal or body CT with intravenous contrastAbdominal or body CT with intravenous contrast | Diagnostic test | Abdominal or body CT with intravenous contrast |
| Abdominal or body CT without intravenous contrast (native CT)Abdominal or body CT without intravenous contrast (native CT) | Diagnostic test | Abdominal or body CT without intravenous contrast (native CT) |
Primary outcome
Mortality or renal replacement therapy
Time frame: Within 90 days from CT
A composite outcome that combines all-cause mortality or renal replacement therapy (number of patients)
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 33028554Raty 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.
- Individual participant dataSharing planned: No. Not shared.
Related trials for Acute Abdomen
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Recruiting
Vision-Language-Based Large-Scale Model for Emergency Screening
Acute Thoraco-Abdominal Emergency Lesions
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Abdominal or body CT with intravenous contrast and Abdominal or body CT without intravenous contrast (native CT) in people with Acute Abdomen and Radiocontrast Nephropathy, run by Helsinki University Central Hospital at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or renal replacement therapy (time frame: Within 90 days from CT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04196244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.