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

This study has been completed.
Sponsor:
Information provided by:
Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00870766
First received: March 26, 2009
Last updated: September 13, 2010
Last verified: September 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870766

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

No publications provided

Responsible Party: Pekka Miettinen, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00870766     History of Changes
Other Study ID Numbers: KUH5200617
Study First Received: March 26, 2009
Last Updated: September 13, 2010
Health Authority: Finland: Ethics Committee

Additional relevant MeSH terms:
Abdomen, Acute
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 22, 2014