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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014