Clinical trial NCT01465711: The Value of PSP in Predicting Outcome in ICU Surgical Peritonitis Patients
Official title: Diagnostic Accuracy of Pancreatic Stone Protein in Predicting Severe Outcome in Patients With Peritonitis at the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Sepsis
Multiple Organ Failure
Death
Keywords: Peritonitis
Sepsis
General Surgery
Intensive Care Units
Sensitivity and Specificity
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2011-11-06
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinics

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Localization of Peritonitis
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: University of Magdeburg
Study officials:
affiliation: University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
name: Walter Halangk, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
name: Hans-Ulrich Schulz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Zurich, Department of Surgery, Raemistrasse 100, CH-8091, Zurich, Switzerland
name: Rolf Graf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gukasjan R, Raptis DA, Schulz HU, Halangk W, Graf R. Pancreatic stone protein predicts outcome in patients with peritonitis in the ICU. Crit Care Med. 2013 Apr;41(4):1027-36. doi: 10.1097/CCM.0b013e3182771193.