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Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis

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.
 
ClinicalTrials.gov Identifier: NCT00630071
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : October 16, 2012
Sponsor:
Information provided by (Responsible Party):
Michael Sand, Ruhr University of Bochum

Tracking Information
First Submitted Date February 26, 2008
First Posted Date March 6, 2008
Last Update Posted Date October 16, 2012
Study Start Date February 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
Official Title A Prospective Study Investigating the Diagnostic Value of Procalcitonin in Patients With Acute Appendicitis
Brief Summary The values of laboratory examinations which are useful for the diagnoses of acute appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). Another laboratory value which has recently received considerable attention for the early diagnosis of bacterial infection and sepsis is pro-calcitonin (PCT). In recent studies it has been clearly shown that PCT is one of the most important biochemical indicators which closely correlates with the severity of inflammatory host response to microbial infections. Aim of this open, prospective study is therefore to investigate if PCT has an accurate diagnostic value for the diagnosis of acute appendicitis.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
1.5 ml whole blood
Sampling Method Non-Probability Sample
Study Population Surgical Emergency Room
Condition Appendicitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Sand M, Trullen XV, Bechara FG, Pala XF, Sand D, Landgrafe G, Mann B. A prospective bicenter study investigating the diagnostic value of procalcitonin in patients with acute appendicitis. Eur Surg Res. 2009;43(3):291-7. doi: 10.1159/000232939. Epub 2009 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 22, 2008)
103
Original Estimated Enrollment
 (submitted: February 26, 2008)
100
Actual Study Completion Date August 2008
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of appendicitis

Exclusion Criteria:

  • Antibiotic therapy
  • Infection at other body sites
  • Age < 14 years
  • Appendectomy in the medical history
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00630071
Other Study ID Numbers PCT 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Michael Sand, Ruhr University of Bochum
Study Sponsor Ruhr University of Bochum
Collaborators Not Provided
Investigators
Study Chair: Benno Mann, PD Dr. med. Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
Principal Investigator: Michael Sand, Dr. med. Department of General and Visceral Surgery, Augusta Krankenanstalt, Academic Teaching Hospital of the Ruhr-University Bochum
PRS Account Ruhr University of Bochum
Verification Date October 2012