Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population

May 14, 2018 updated by: University of Zurich

Peri-operative Expression Analysis of Pancreatic Stone Protein and Pancreatitis-associated Protein in a Surgical Study Population

The purpose of this study is to analyze the peri-operative expression of pancreatic stone protein and pancreatitis-associated protein in surgical patients following major abdominal surgery by blood samples.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

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

  • Switzerland
    • CH/Zürich
      • Zurich, CH/Zürich, Switzerland, 8091
        • Department of Visceral and Transplantation Surgery

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing major abdominal surgery

Description

Inclusion criteria: - >= 18 years

  • abdominal major surgery
  • need for post-operative ICU care

Exclusion criteria: - <18 years

- patients who do not agree the written informed consent

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sepsis Group
Patients suffering from sepsis in the postoperative course after major abdominal surgery
Other: Analysis of PSP and PAP from venous blood samples
to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery
Control Group
Patients without suffering sepsis during postoperative follow up after major abdominal surgery
Other: Analysis of PSP and PAP from venous blood samples
to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensive Care Unit (ICU) stay in days
Time Frame: 2 years
2 years
hospital stay in days
Time Frame: 2 years
2 years
postoperative complications according to the "Clavien-Dindo Classification" System
Time Frame: 2 years
2 years
hospital costs
Time Frame: 2 years
2 years
comparisons to other known infectious parameters: c-reactive protein (CRP), procalcitonin (PCT), Interleukin 6 (IL-6), Tumor Necrosis Factor Alpha (TNF-alpha), Leucocytes
Time Frame: 2 years
2 years
Bacteriaemia in the blood
Time Frame: 2 years
2 years
Platelets in the blood
Time Frame: 2 years
2 years

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Christian E Oberkofler, MD, UniversitaetsSpital Zuerich

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 (Actual)

February 1, 2011

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Actual)

May 17, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 11.2009

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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