ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01465711
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Antje Wiede, 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).

Condition or disease Intervention/treatment
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 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 : July 2007
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort 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 Name: surgical procedures
Procedure: Intubation
Ventilatory support
Other Name: Endotracheal Intubation, tracheostomy
Radiation: Imaging
Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging
Other Name: 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 Name: surgical procedures
Procedure: Intubation
Ventilatory support
Other Name: Endotracheal Intubation, tracheostomy
Radiation: Imaging
Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging
Other Name: Any type of diagnostic or interventional imaging technique



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


Biospecimen Retention:   Samples Without DNA
Whole blood, serum, plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01465711


Locations
Germany
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Antje Wiede, Investigator, University of Magdeburg
ClinicalTrials.gov Identifier: NCT01465711     History of Changes
Other Study ID Numbers: 33/01
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: November 2011

Keywords provided by Antje Wiede, University of Magdeburg:
Peritonitis
Sepsis
General Surgery
Intensive Care Units
Sensitivity and Specificity

Additional relevant MeSH terms:
Sepsis
Peritonitis
Multiple Organ Failure
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Intraabdominal Infections
Peritoneal Diseases
Digestive System Diseases
Shock