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

Terminated

• Conditions: Patients Undergoing Major Abdominal Surgery
• Interventions: Other: Analysis of PSP and PAP from venous blood samples

• Registration Number: NCT01258179
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-07
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-02
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sepsis Group	Analysis of PSP and PAP from venous blood samples	Patients suffering from sepsis in the postoperative course after major abdominal surgery
Control Group	Analysis of PSP and PAP from venous blood samples	Patients without suffering sepsis during postoperative follow up after major abdominal surgery

Primary Outcome Measures

Name	Time	Method
Diagnosed Infections according to the Systemic Inflammatory Response System (SIRS) Criteria of the german interdisciplinary Association of Intensive and Emergency Medicine	2 years

Secondary Outcome Measures

Name	Time	Method
hospital costs	2 years
hospital stay in days	2 years
postoperative complications according to the "Clavien-Dindo Classification" System	2 years
Bacteriaemia in the blood	2 years
Platelets in the blood	2 years
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
Intensive Care Unit (ICU) stay in days	2 years

Trial Locations

Locations (1)

Department of Visceral and Transplantation Surgery; 🇨🇭 Zurich, CH/Zürich, Switzerland