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

December 2, 2014 updated by: Antje Wiede, University of Magdeburg

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Magdeburg, Germany
        • University of Magdeburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Magdeburg

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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