Peri-operative Expression Analysis of Pancreatic Stone Protein in a Surgical Study Population
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Zurich.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Zurich
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01258179
First received: December 7, 2010
Last updated: February 2, 2011
Last verified: February 2011
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Purpose
The purpose of this study is to analyze the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery by blood samples.
| Condition | Intervention | Phase |
|---|---|---|
|
Patients Undergoing Major Abdominal Surgery |
Other: Analysis of PSP 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 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: | 283 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (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 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 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 | |
| Départment 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: | OBERKOFLER Christian Eugen, Dr., University Hospital Zurich, VIS Klinik für Viszeralchirurgie |
| ClinicalTrials.gov Identifier: | NCT01258179 History of Changes |
| Other Study ID Numbers: | 11.2009 |
| Study First Received: | December 7, 2010 |
| Last Updated: | February 2, 2011 |
| Health Authority: | Switzerland: KEK Zurich |
ClinicalTrials.gov processed this record on May 21, 2013