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Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis (MaSep)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01535534
Recruitment Status : Active, not recruiting
First Posted : February 17, 2012
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim

Tracking Information
First Submitted Date February 14, 2012
First Posted Date February 17, 2012
Last Update Posted Date August 27, 2020
Actual Study Start Date January 2012
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Official Title Evaluation of Mediators of Inflammation, Prognostic Markers and Genetic Polymorphisms in Patients With Sepsis
Brief Summary During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.
Detailed Description

Primary Outcome Measures:

New diagnostic and prognostic markers for septic patients

Estimated Enrollment: 300 patients Study Start Date: January 2012 Estimated Study Completion Date: open Estimated Primary Completion Date: open

Intervention Details:

Procedure: vein puncture comparison of different inflammatory markers in the blood of septic patients

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Peripheral blood samples
Sampling Method Probability Sample
Study Population Patients suffering from sepsis
Condition Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 26, 2020)
250
Original Estimated Enrollment
 (submitted: February 16, 2012)
300
Estimated Study Completion Date December 2021
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • SIRS-Criteria
  • Proven Infection
  • One sepsis-induced organ-failure
  • Adults < 18 years old

Exclusion Criteria:

  • Anemia
  • Pregnancy
  • Blood donor in the last 3 month
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01535534
Other Study ID Numbers 2011-384N-MA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. med. Ursula Hoffmann, Universitätsmedizin Mannheim
Study Sponsor Universitätsmedizin Mannheim
Collaborators Not Provided
Investigators
Principal Investigator: Ursula Hoffmann, MD Universitätsmedizin Mannheim
Study Director: Michael Behnes, MD Universitätsmedizin Mannheim
PRS Account Universitätsmedizin Mannheim
Verification Date August 2020