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

Completed

• Conditions: Peritonitis; Multiple Organ Failure; Death; Sepsis
• Interventions: Procedure: All abdominal surgical procedures; Procedure: Intubation; Radiation: Imaging

• Registration Number: NCT01465711
• Lead Sponsor: University of Magdeburg

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2011-10-28
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-04
• Study First Posted: 2011-11-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Peritonitis	Imaging	Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis
Peritonitis	All abdominal surgical procedures	Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis
Peritonitis	Intubation	Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis
Control	All abdominal surgical procedures	Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.
Control	Intubation	Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.
Control	Imaging	Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.

Primary Outcome Measures

Name	Time	Method
Localization of Peritonitis	up to 2 months	Localised vs. diffused. A clinical finding intra-operatively and/or radiologically (i.e. CT or MRI)

Trial Locations

Locations (1)

University of Magdeburg; 🇩🇪 Magdeburg, Germany