Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU

Completed

• Conditions: SIRS; Sepsis

• Registration Number: NCT01236703
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

CRP and PCT are not valid parameters of early infection in particularly postoperative patients. (Sanders et al., A\&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol 15.2) Better detection systems for SIRS and sepsis are urgently required.

ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood.

The purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative patients. Furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2010-05
• Study Completion: 2010-10
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• all ICU patients age > 18 years
• more than 36h on ICU

Exclusion Criteria

• ICU patients age < 18 years
• less than 36h on ICU

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study performed according to an observational post-ad-hoc design is to show that the two Sysmex infection scores provide a better performance than CRP & PCT for infection processes thus providing an efficient alternative.	a period of 60 days	Approximately 200 patients will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days. Usually in clinical routine, patients suspected to have an infection process, receive once per day a "full infectiology profile". It consists of CRP, PCT and the Sysmex infection profiles (ICIS/ICPS).

Secondary Outcome Measures

Name	Time	Method
The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT.	a period of 60 day	Approximately 200 patients will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days. Usually in clinical routine, patients suspected to have an infection process, receive once per day a "full infectiology profile". It consists of CRP, PCT and the Sysmex infection profiles (ICIS/ICPS).

Trial Locations

Locations (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany