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

NCT01465711 — Completed, 137 participants, University of Magdeburg

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01465711
Status	Completed
Study type	Observational
Enrollment	137 (Actual)
Sponsor	University of Magdeburg (Other); collaborators: University of Zurich
Conditions	Peritonitis, Sepsis, Multiple Organ Failure, Death
Interventions	All abdominal surgical procedures, Intubation, Imaging (Procedure, radiation)
Dates	start 2007-07-01, primary completion 2014-12-01, completion 2014-12-01, first posted 2011-11-07, last updated 2014-12-03
Locations	1 site in Germany

-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).

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Control		Procedure: All abdominal surgical procedures; Procedure: Intubation; Radiation: Imaging	Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.
Peritonitis		Procedure: All abdominal surgical procedures; Procedure: Intubation; Radiation: Imaging	Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis

All abdominal surgical procedures (Procedure), also known as surgical procedures: Laparotomy, Laparoscopy
Intubation (Procedure), also known as Endotracheal Intubation, tracheostomy: Ventilatory support
Imaging (Radiation), also known as Any type of diagnostic or interventional imaging technique: Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 18 Years to 90 Years

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.

+Locations (1)

Facility	City	Country	Status
University of Magdeburg	Magdeburg	Germany

+Publications

Results publication: 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. PMID 23399938

+Investigators

Walter Halangk, PhD, Principal investigator, University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
Hans-Ulrich Schulz, MD, Principal investigator, University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany
Rolf Graf, PhD, Principal investigator, University Hospital Zurich, Department of Surgery, Raemistrasse 100, CH-8091, Zurich, Switzerland