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

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ClinicalTrials.gov Identifier: NCT01258179
Recruitment Status : Recruiting
First Posted : December 10, 2010
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Patients Undergoing Major Abdominal Surgery Other: Analysis of PSP and PAP from venous blood samples

Study Design

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peri-operative Expression Analysis of Pancreatic Stone Protein and Pancreatitis-associated Protein in a Surgical Study Population
Study Start Date : February 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Intensive Care Unit (ICU) stay in days [ Time Frame: 2 years ]
  2. hospital stay in days [ Time Frame: 2 years ]
  3. postoperative complications according to the "Clavien-Dindo Classification" System [ Time Frame: 2 years ]
  4. hospital costs [ Time Frame: 2 years ]
  5. 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 ]
  6. Bacteriaemia in the blood [ Time Frame: 2 years ]
  7. Platelets in the blood [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Venous blood samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing major abdominal surgery
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258179


Contacts
Contact: Christian E Oberkofler, MD +41 (0)44 255 11 11 christian.oberkofler@usz.ch
Contact: Rolf Graf, Prof. PhD +41 (0)44 255 2071 rolf.graf@usz.ch

Locations
Switzerland
Department of Visceral and Transplantation Surgery Recruiting
Zurich, CH/Zürich, Switzerland, 8091
Contact: Christian E Oberkofler, MD    +41- (0)44 255 1111    christian.oberkofler@usz.ch   
Contact: Rolf Graf, Prof. PhD    +41- (0)44 255 2071    rolf.graf@usz.ch   
Principal Investigator: Christian E Oberkofler, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Christian E Oberkofler, MD UniversitaetsSpital Zuerich