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

NCT ID: NCT01465711

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Peritonitis Sepsis Multiple Organ Failure Death

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Control

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

All abdominal surgical procedures

Intervention Type PROCEDURE

Laparotomy, Laparoscopy

Intubation

Intervention Type PROCEDURE

Ventilatory support

Imaging

Intervention Type RADIATION

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Peritonitis

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

All abdominal surgical procedures

Intervention Type PROCEDURE

Laparotomy, Laparoscopy

Intubation

Intervention Type PROCEDURE

Ventilatory support

Imaging

Intervention Type RADIATION

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Interventions

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All abdominal surgical procedures

Laparotomy, Laparoscopy

Intervention Type PROCEDURE

Intubation

Ventilatory support

Intervention Type PROCEDURE

Imaging

Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging

Intervention Type RADIATION

Other Intervention Names

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surgical procedures Endotracheal Intubation, tracheostomy Any type of diagnostic or interventional imaging technique

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

University of Magdeburg

OTHER

Sponsor Role lead

Responsible Party

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Antje Wiede

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walter Halangk, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany

Hans-Ulrich Schulz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg, Department of General, Visceral and Vascular Surgery, Leipziger Str. 44, DE-39120, Magdeburg, Germany

Rolf Graf, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Department of Surgery, Raemistrasse 100, CH-8091, Zurich, Switzerland

Locations

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University of Magdeburg

Magdeburg, , Germany

Site Status

Countries

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Germany

References

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Gukasjan R, Raptis DA, Schulz HU, Halangk W, Graf R. Pancreatic stone protein predicts outcome in patients with peritonitis in the ICU. Crit Care Med. 2013 Apr;41(4):1027-36. doi: 10.1097/CCM.0b013e3182771193.

Reference Type DERIVED
PMID: 23399938 (View on PubMed)

Other Identifiers

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33/01

Identifier Type: -

Identifier Source: org_study_id