SepsisNCT00527384
Biomarker Analysis of Stress
An observational study of Sepsis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to May 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients at Wadsworth Center with Sepsis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarker Signatures of Biological, Chemical, or Psychological Stress
Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.
Read the detailed description
Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.
- Conditions
- Sepsis
- Keywords
- Stress
- Medical subject headings
- Sepsis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- David A. Lawrence, Ph.D., Principal investigator, Wadsworth Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527384
- Sponsor's protocol ID
- 16014-CP-001
- Status last verified
- Apr 2015
- First submitted
- 6 Sep 2007
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Signatures of Biological, Chemical, or Psychological Stress
- ClinicalTrials.gov ID
- NCT00527384
- Acronym / sponsor ID
- 16014-CP-001
- Conditions
- Sepsis
- Keywords
- Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Oct 2007
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Sep 2007 (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.
Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.
Detailed description
Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients at Wadsworth Center with Sepsis
Key exclusion criteria (0 listed)
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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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.
David A. Lawrence, Ph.D. principal investigator
Wadsworth Center
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 Sepsis, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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 1 inclusion and 0 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: finished, as of the sponsor's last update on 14 Apr 2015. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 14 Apr 2015.