The Value of PSP in Predicting Outcome in ICU Surgical Peritonitis Patients

Sepsis Clinical Trial

Official title:

Diagnostic Accuracy of Pancreatic Stone Protein in Predicting Severe Outcome in Patients With Peritonitis at the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465711
• Other study ID #: 33/01
• Status: Completed
• Phase: N/A
• First received: October 28, 2011
• Last updated: December 2, 2014
• Start date: July 2007
• Est. completion date: December 2014

Study information

• Verified date: November 2011
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesSwitzerland: Swissmedic
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine the diagnostic accuracy of Pancreatic Stone Protein (PSP) in predicting patient outcomes with suspected peritonitis in the Intensive Care Unit after abdominal surgery and compare PPS with other blood parameters, including C-Reactive Protein (CRP), White Cell Count (WCC), Interleucin-6 (IL-6) and Procalcitonin (PCT).

Description:

Peritonitis is a severe complication after abdominal surgery. Patients admitted at the Intensive Care Unit (ICU) following surgery bear the risk of localized infection, sepsis or septic shock. Prevention or early detection of such events is important to intervene with an appropriate therapeutic action and avoid risking a potentially life-threatening situation. White blood cell counts (WCC) and C-Reactive Protein (CRP), Interleucin-6 (IL-6) and Procalcitonin (PCT) have all been promising parameters, however, they are useful only in selective cases and have a limited diagnostic accuracy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Abdominal surgery.

• Admission to the Intensive Care Unit (ICU).

• Blood sampling within 3 hours from admission to the ICU

• Patient over 18 years of age

Exclusion Criteria:

• Patients already treated for peritonitis.

• Patients referred from other hospitals with suspicion of peritonitis

• Patient age less than 18 years of age.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Death
• Multiple Organ Failure
• Peritonitis
• Sepsis

Intervention

Procedure:
• All abdominal surgical procedures
Laparotomy, Laparoscopy
• Intubation
Ventilatory support

Radiation:
• Imaging
Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Locations

Country	Name	City	State
Germany	University of Magdeburg	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	University of Zurich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Localization of Peritonitis	Localised vs. diffused. A clinical finding intra-operatively and/or radiologically (i.e. CT or MRI)	up to 2 months	No