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Computer Tomography (CT) Trial of Acute Abdomen (PRACTA)

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ClinicalTrials.gov Identifier: NCT00870766
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : September 14, 2010
Information provided by:
Kuopio University Hospital

Brief 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.

Condition or disease Intervention/treatment
Acute Abdomen Procedure: Abdominal contrast-enhanced CT scanning

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : January 2009
Primary Completion Date : January 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: CT
All patients in the CT arm undergo abdominal CT scanning within 24 hours of admission to the ER.
Procedure: Abdominal contrast-enhanced CT scanning
Contrast-enhanced (iohexol 350 mgI/ml, 100 ml IV) CT scanning
No Intervention: Current practice
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.

Primary Outcome Measures :
  1. Diagnostic accuracy [ Time Frame: at discharge and/or 2-3 mo follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age > 18
  • abdominal pain > 2h and < 7 days

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870766

Kuopio University Hospital
Kuopio, Finland
Sponsors and Collaborators
Kuopio University Hospital

Responsible Party: Pekka Miettinen, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00870766     History of Changes
Other Study ID Numbers: KUH5200617
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Abdomen, Acute
Abdominal Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Digestive