We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00870766
First Posted: March 27, 2009
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kuopio University Hospital
  Purpose
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 Intervention
Acute Abdomen Procedure: Abdominal contrast-enhanced CT scanning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Kuopio University Hospital:

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

Estimated Enrollment: 250
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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


Locations
Finland
Kuopio University Hospital
Kuopio, Finland
Sponsors and Collaborators
Kuopio University Hospital
  More Information

Responsible Party: Pekka Miettinen, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00870766     History of Changes
Other Study ID Numbers: KUH5200617
First Submitted: March 26, 2009
First Posted: March 27, 2009
Last Update Posted: September 14, 2010
Last Verified: September 2010

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