NCT00814112

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2008

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

December 22, 2008

Last Update Submit

March 13, 2024

Conditions

Septic Shock

Study Arms (2)

1 septic shock

septic shock, ICU

2 controls

matched controls

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Septic Shock

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • \>24h post sepsis diagnosis
  • Ongoing oral or intravenous cortisone treatment for more than one month.
  • Malignancy with metastasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intensive Care Unit, Lund University Hospital

Lund, 22185, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma and Urine.

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Mikael Bodelsson, professor

    Intensive Care Unit, Lund University Hospital, Sweden

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

SE(1)