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

This study is currently recruiting participants.
Verified February 2014 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
Christian E. Oberkofler, University of Zurich
ClinicalTrials.gov Identifier:
NCT01258179
First received: December 7, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Patients Undergoing Major Abdominal Surgery
Other: Analysis of PSP and PAP from venous blood samples
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Intensive Care Unit (ICU) stay in days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • hospital stay in days [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • postoperative complications according to the "Clavien-Dindo Classification" System [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • hospital costs [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Bacteriaemia in the blood [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Platelets in the blood [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Venous blood samples


Estimated Enrollment: 160
Study Start Date: February 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Christian E. Oberkofler, Principle Investigator, University of Zurich
ClinicalTrials.gov Identifier: NCT01258179     History of Changes
Other Study ID Numbers: 11.2009
Study First Received: December 7, 2010
Last Updated: February 3, 2014
Health Authority: Switzerland: KEK Zurich

ClinicalTrials.gov processed this record on April 21, 2014