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

Patients Undergoing Major Abdominal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01258179
• Other study ID #: 11.2009
• Status: Terminated
• Start date: February 2011
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Major Abdominal Surgery

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Visceral and Transplantation Surgery	Zurich	CH/Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine		2 years
Secondary	Intensive Care Unit (ICU) stay in days		2 years
Secondary	hospital stay in days		2 years
Secondary	postoperative complications according to the "Clavien-Dindo Classification" System		2 years
Secondary	hospital costs		2 years
Secondary	comparisons to other known infectious parameters: c-reactive protein (CRP), procalcitonin (PCT), Interleukin 6 (IL-6), Tumor Necrosis Factor Alpha (TNF-alpha), Leucocytes		2 years
Secondary	Bacteriaemia in the blood		2 years
Secondary	Platelets in the blood		2 years