Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU
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|ClinicalTrials.gov Identifier: NCT01236703|
Recruitment Status : Completed
First Posted : November 9, 2010
Last Update Posted : January 5, 2012
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||207 participants|
|Official Title:||Hematological Infection Profile (ICIS/ICPS) Compared to Actual Best Hospital Practice for Differentiation of SIRS and Sepsis and Management of Antiinfective Therapy in ICU Patients|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||October 2010|
ICU patients (post-operative and none operative patients) will be enrolled in the study. They are followed up until the end of ICU stay or, for a maximum of 60 days.
- 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. [ Time Frame: 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).
- The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT. [ Time Frame: 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).
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): NCT01236703
|Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum|
|Berlin, Germany, 13353|
|Study Director:||Claudia Spies, MD Prof.||Charite University, Berlin, Germany|