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OpenTrials
Completed

NCT Number: NCT01465711

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

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).

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Key information

Conditions

Peritonitis Death Digestive System Diseases Hypersensitivity Immune System Diseases Infections Inflammation Intraabdominal Infections Multiple Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Sepsis Shock Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Magdeburg

Magdeburg, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

All abdominal surgical procedures

Procedure

Laparotomy, Laparoscopy

Other names: surgical procedures

Intubation

Procedure

Ventilatory support

Other names: Endotracheal Intubation, tracheostomy

Imaging

Radiation

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Other names: Any type of diagnostic or interventional imaging technique

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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