Indicators of Inflammation and Coagulation in Sepsis
This study is currently recruiting participants.
Verified January 2013 by University of Oklahoma
Sponsor:
University of Oklahoma
Information provided by (Responsible Party):
Gary Kinasewitz, University of Oklahoma
ClinicalTrials.gov Identifier:
NCT01128283
First received: May 20, 2010
Last updated: January 31, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 20, 2010 | ||||||||
| Last Updated Date | January 31, 2013 | ||||||||
| Start Date ICMJE | January 2002 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Death [ Time Frame: 30 days ] [ Designated as safety issue: No ] Survival at 30 days |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01128283 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Indicators of Inflammation and Coagulation in Sepsis | ||||||||
| Official Title ICMJE | Temporal Behavior of Coagulation Factors, Cytokines and Tissue Injury Markers in Sepsis | ||||||||
| Brief Summary | We will collect blood samples from patients with the diagnosis of sepsis and other ICU patients. We will describe the course of different mediator levels and organ injury markers and follow their progression throughout the course of the study. |
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| Detailed Description | After informed consent is obtained 5 cc of blood is collected on the day of admission and on days 0, 1, 3, and 7 thereafter. Plasma is collected and frozen for the subsequent measurement of biomarkers. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Plasma |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | ICU patients |
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| Condition ICMJE | Sepsis | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01128283 | ||||||||
| Other Study ID Numbers ICMJE | 09681 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Gary Kinasewitz, University of Oklahoma | ||||||||
| Study Sponsor ICMJE | University of Oklahoma | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Oklahoma | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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