- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02120534
Serum CD14 and CD88 Mointoring in ICU
December 14, 2014 updated by: Ayman Abd Al-maksoud Yousef, Tanta University
The Predictive Values of Serum Soluble CD14 Subtype and CD88 Monitoring in Critically Ill Patients.
The present study will be conducted to determine the dynamic changes of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients.
Study Overview
Status
Completed
Conditions
Detailed Description
A total of ninty four will be included in the study.
Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group).
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured.
Routine cultures will be obtained.
The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of CD 14 and CD88 will be monitored.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Algharbyia
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Tanta, Algharbyia, Egypt, 35217
- Tanta University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
A total of ninety-four patients will be included in the study.
Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group) and forty seven patients are critically ill without evidence of infectious organism (SIRS group).
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured.
Routine cultures will be obtained.
The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of CD 14 and CD88 will be monitored.
Description
Inclusion Criteria:
- The patients staying in ICU for more than 24 hours will be included in the study.
Exclusion Criteria:
- Patients received anti-inflammatory drugs or corticosteroids before admission, patients had immunosuppressive illness, patients had chronic organ failure; patients received massive blood transfusion; patients with radiation therapy and patients with previous organ transplantation will be excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Sepsis group
Forty seven patients are critically ill with evidence of sepsis during ICU stay (sepsis group).
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured.
Routine cultures will be obtained.
The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of CD 14 and CD88 will be monitored.
|
|
SIRS group
Forty seven patients are critically ill without evidence of infectious organism (SIRS group).
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured.
Routine cultures will be obtained.
The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of CD 14 and CD88 will be monitored.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A serum soluble CD14
Time Frame: one week
|
At admission, Patients data include clinical status; SOFA score; central venous pressure; laboratory analysis and arterial blood gas analysis are measured.
Routine cultures will be obtained.
The attending physician will evaluate the patients for sepsis, severe sepsis, or septic shock as long as their stay in ICU.
A serum level of CD 14 will be monitored.
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Survival of ICU patients
Time Frame: Two weeks
|
Correlation of of serum soluble CD14 and the corresponding changes of serum CD88 and their correlation in critically ill sepsis and SIRS patients and survival.
|
Two weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
April 18, 2014
First Submitted That Met QC Criteria
April 18, 2014
First Posted (Estimate)
April 22, 2014
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 14, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1638/02/13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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