Septic ShockGAGSNCT00814112
Glycosaminoglycans During Septic Shock - a Temporal Study
An observational study of Septic Shock, run by Region Skane at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Septic Shock
Who may be able to join
- 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
Who cannot join
- Pregnancy
- >24h post sepsis diagnosis
- Ongoing oral or intravenous cortisone treatment for more than one month.
- Malignancy with metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GAGS - Glykosaminoglykaner Vid Sepsis
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.
- Conditions
- Septic Shock
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 septic shock | septic shock, ICU | |
| 2 controls | matched controls |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startNov 2008 (estimated)
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Why it stopped: Lack of personell
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikael Bodelsson, professor, Principal investigator, Intensive Care Unit, Lund University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814112
- Sponsor's protocol ID
- GAGS 293/2008
- Acronym
- GAGS
- Status last verified
- Mar 2024
- First submitted
- 22 Dec 2008
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GAGS - Glykosaminoglykaner Vid Sepsis
- ClinicalTrials.gov ID
- NCT00814112
- Acronym / sponsor ID
- GAGS / GAGS 293/2008
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lack of personell
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Nov 2008 (estimated)
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 septic shock | – | –septic shock, ICU |
| 2 controls | – | –matched controls |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Septic Shock
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnancy
- >24h post sepsis diagnosis
- Ongoing oral or intravenous cortisone treatment for more than one month.
- Malignancy with metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
Related trials for Septic Shock
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A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
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Serum GDF-15 and LGALS3BP as Prognostic Biomarkers in Sepsis
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Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
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Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Bodelsson, professor principal investigator
Intensive Care Unit, Lund University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.