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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 : Terminated (low recruitment)
First Posted : December 10, 2010
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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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
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Study Type : Observational
Actual Enrollment : 30 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
Actual Study Start Date : February 2011
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

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Groups and Cohorts
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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
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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
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
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
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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


Locations
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Switzerland
Department of Visceral and Transplantation Surgery
Zurich, CH/Zürich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Christian E Oberkofler, MD UniversitaetsSpital Zuerich
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01258179    
Other Study ID Numbers: 11.2009
First Posted: December 10, 2010    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018