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Glycosaminoglycans During Septic Shock - a Temporal Study (GAGS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Region Skane.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00814112
First Posted: December 23, 2008
Last Update Posted: October 8, 2009
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.
Information provided by:
Region Skane
  Purpose
We have previously shown that the plasma level of glycosaminoglycans (GAG) in septic shock patients are elevated compared to controls. The purpose of this study is to investigate the temporal dynamic of the blood level of GAG in ten septic shock patients. In addition, to assess the kinetics of GAG during septic shock we examine the liver function by galactose elimination capacity as well as excreted urinary GAG.

Condition
Septic Shock

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: GAGS - Glykosaminoglykaner Vid Sepsis

Resource links provided by NLM:


Further study details as provided by Region Skane:

Biospecimen Retention:   Samples Without DNA
Plasma and Urine.

Estimated Enrollment: 20
Study Start Date: November 2008
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 septic shock
septic shock, ICU
2 controls
matched controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Septic Shock
Criteria

Inclusion Criteria:

  • 2 out of 4 SIRS criteria, where the circulatory criteria must be fulfilled
  • Clinical sepsis is suspected
  • Informed consent from relative
  • Study subject must be over 18 years old

Exclusion Criteria:

  • Pregnancy
  • >24h post sepsis diagnosis
  • Ongoing oral or intravenous cortisone treatment for more than one month.
  • Malignancy with metastasis
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00814112


Contacts
Contact: Ingrid Berkestedt, MD PhD +4646171949 ingrid.berkestedt@skane.se
Contact: Axel Nelson, PhD-student axel.nelson@med.lu.se

Locations
Sweden
Intensive Care Unit, Lund University Hospital Recruiting
Lund, Sweden, 22185
Contact: Ingrid Berkestedt, MD PhD    +4646171949    ingrid.berkestedt@skane.se   
Sub-Investigator: Axel Nelson, PhD student         
Sub-Investigator: Ingrid Berkestedt, MD PhD         
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Mikael Bodelsson, professor Intensive Care Unit, Lund University Hospital, Sweden
  More Information

Responsible Party: Mikael Bodelsson/Professor, Lund University Hospital
ClinicalTrials.gov Identifier: NCT00814112     History of Changes
Other Study ID Numbers: GAGS 293/2008
First Submitted: December 22, 2008
First Posted: December 23, 2008
Last Update Posted: October 8, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation