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

Sponsor

University of Magdeburg (Other)

Overall Status

Completed

CT.gov ID

NCT01465711

Collaborator

University of Zurich (Other)

137

Enrollment

Location

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Peritonitis Sepsis Multiple Organ Failure Death	Procedure: All abdominal surgical procedures Procedure: Intubation Radiation: Imaging

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 Design

Study Type:

Observational

Actual Enrollment :

137 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2007

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Control Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.	Procedure: All abdominal surgical procedures Laparotomy, Laparoscopy Other Names: surgical procedures Procedure: Intubation Ventilatory support Other Names: Endotracheal Intubation, tracheostomy Radiation: Imaging Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging Other Names: Any type of diagnostic or interventional imaging technique
Peritonitis Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis	Procedure: All abdominal surgical procedures Laparotomy, Laparoscopy Other Names: surgical procedures Procedure: Intubation Ventilatory support Other Names: Endotracheal Intubation, tracheostomy Radiation: Imaging Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging Other Names: Any type of diagnostic or interventional imaging technique

Arm

Intervention/Treatment

Control

Admission to the Intensive Care Unit (ICU) after abdominal surgery without suspicion / evidence of peritonitis.

Procedure: All abdominal surgical procedures

Laparotomy, Laparoscopy

Other Names:

surgical procedures

Procedure: Intubation

Ventilatory support

Other Names:

Endotracheal Intubation, tracheostomy

Radiation: Imaging

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Other Names:

Any type of diagnostic or interventional imaging technique

Peritonitis

Admission to the Intensive Care Unit (ICU) after abdominal surgery with suspicion / evidence of peritonitis

Procedure: All abdominal surgical procedures

Laparotomy, Laparoscopy

Other Names:

surgical procedures

Procedure: Intubation

Ventilatory support

Other Names:

Endotracheal Intubation, tracheostomy

Radiation: Imaging

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Other Names:

Any type of diagnostic or interventional imaging technique

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Magdeburg	Magdeburg		Germany

Sponsors and Collaborators

University of Magdeburg
University of Zurich

Investigators

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