Acute AbdomenPRACTANCT00870766
Computer Tomography (CT) Trial of Acute Abdomen
A study testing Abdominal contrast-enhanced CT scanning in people with Acute Abdomen, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen
- What is being tested?
- Abdominal contrast-enhanced CT scanning
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age > 18
- abdominal pain > 2h and < 7 days
Who cannot join
- pregnancy
- acute abdominal trauma
- allergy to iodinated contrast media
- severe renal insufficiency
- metformin medication combined with elevated plasma creatinin level
- lack of cooperation (if informed consent is not possible)
- abdominal pain combined with bleeding shock
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.
- Conditions
- Acute Abdomen
- Being tested
- Abdominal contrast-enhanced CT scanning
- 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 contrast-enhanced CT scanningProcedure or surgery
Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning
| Study group | Role | What they receive |
|---|---|---|
| CT | Active comparator | All patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER. Receives: Procedure: Abdominal contrast-enhanced CT scanning |
| Current practice | No intervention | The patients in the current practice arm are referred to radiological examinations, such as US, plain radiography or CT, based on the clinical need only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy
Measured: at discharge and/or 2-3 mo follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870766
- Sponsor's protocol ID
- KUH5200617
- Acronym
- PRACTA
- Status last verified
- Sep 2010
- First submitted
- 26 Mar 2009
- Last updated
- 14 Sep 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Tomography (CT) Trial of Acute Abdomen
- ClinicalTrials.gov ID
- NCT00870766
- Acronym / sponsor ID
- PRACTA / KUH5200617
- Conditions
- Acute Abdomen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Mar 2009 (estimated)
- 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.
The purpose of this study is to determine the impact of routinely performed early CT scanning in terms of diagnostic accuracy, patient management and cost-effectiveness compared to current imaging practice in patients suffering from acute abdomen.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT | Active comparator | Procedure: Abdominal contrast-enhanced CT scanningAll patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER. |
| Current practice | No intervention | –The patients in the current practice arm are referred to radiological examinations, such as US, plain radiography or CT, based on the clinical need only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age > 18
- abdominal pain > 2h and < 7 days
Key exclusion criteria (7 listed)
- pregnancy
- acute abdominal trauma
- allergy to iodinated contrast media
- severe renal insufficiency
- metformin medication combined with elevated plasma creatinin level
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 contrast-enhanced CT scanningContrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning | Procedure or surgery | CT |
Primary outcome
Diagnostic accuracy
Time frame: at discharge and/or 2-3 mo follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2010.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal contrast-enhanced CT scanning in people with Acute Abdomen, run by Kuopio University Hospital at 1 site 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 14 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: at discharge and/or 2-3 mo follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2010.