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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Antje Wiede, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01465711
First received: October 28, 2011
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

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 Intervention
Peritonitis
Sepsis
Multiple Organ Failure
Death
Procedure: All abdominal surgical procedures
Procedure: Intubation
Radiation: Imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Secondary Outcome Measures:
  • Localization of Peritonitis [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    Localised vs. diffused. A clinical finding intra-operatively and/or radiologically (i.e. CT or MRI)

  • Severity of Peritonitis [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    None vs. Minor vs. Moderate vs. Severe. A clinical finding intra-operatively and/or radiologically diagnosed.

  • Organ failure [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
    None, vs. single, vs. multiple, total number of organs failed. A clinical diagnosis based on the treatment for organ failure (i.e. heart, renal support) or liver failure based on clinical and laboratory findings.


Biospecimen Retention:   Samples Without DNA

Whole blood, serum, plasma


Estimated Enrollment: 137
Study Start Date: July 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Magdeburg

Additional 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
Study First Received: October 28, 2011
Last Updated: November 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on August 18, 2014