Septic ShockNCT00378586
Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock
An observational study of Septic Shock, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Septic Shock
- What is being tested?
- Rectal biopsy, Measurement of inflammatory markers in the rectal mucosa and Measurement of rectal lactic acid
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Septic shock patients.
Who may be able to join
- Septic shock
Who cannot join
- Age < 18 years
- No next of kin
- Pathology of the descending or sigmoid colon or rectum
- Pregnancy
- 1st degree relatives with inflammatory bowel disease
- Severe coagulopathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Intensive Care 4131
Copenhagen, DK-2100
Michael Ibsen, MD, +45 45 35 94 18, micibs@dadlnet.dk
About this study
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers.
The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.
- Conditions
- Septic Shock
- Being tested
- Rectal biopsy, Measurement of inflammatory markers in the rectal mucosa, Measurement of rectal lactic acid
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal biopsyProcedure or surgery
Rectal biopsy.
Measurement of inflammatory markers in the rectal mucosaProcedure or surgery
IL-6, TNF-alfa.
Measurement of rectal lactic acidProcedure or surgery
Equilibrium dialysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2006 (estimated)
- Study startJan 2010
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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Michael Ibsen, MD, Principal investigator, Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378586
- Sponsor's protocol ID
- KA-05037
- Status last verified
- Jun 2009
- First submitted
- 19 Sep 2006
- Last updated
- 23 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barrier Function and Production of Inflammatory Cytokines in the Rectal Mucosa in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT00378586
- Acronym / sponsor ID
- KA-05037
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Jan 2010
- First posted
- 20 Sep 2006 (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.
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of different inflammatory and infectious markers.
The investigators hypothesize, therefore, that there is a significant difference in the concentrations of inflammatory and infectious markers in the rectal mucosa between patients with septic shock and healthy controls.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients.
Key inclusion criteria (1 listed)
- Septic shock
Key exclusion criteria (6 listed)
- Age < 18 years
- No next of kin
- Pathology of the descending or sigmoid colon or rectum
- Pregnancy
- 1st degree relatives with inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal biopsyRectal biopsy. | Procedure or surgery | – |
| Measurement of inflammatory markers in the rectal mucosaIL-6, TNF-alfa. | Procedure or surgery | – |
| Measurement of rectal lactic acidEquilibrium dialysis. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2009.
Related trials for Septic Shock
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Longitudinal Trajectories of Myocardial Work in Patients With Sepsis
Sepsis, Septic Shock Hyperdynamic
RecruitingObservational study
Immunothrombosis With Septic Shock Undergoing Renal Replacement Therapy With the OXIRIS Membrane
Sepsis
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.
Michael Ibsen, MD principal investigator
Dept. of Intensive Care 4131, Rigshospitalet, Copenhagen, Denmark
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 Herlev Hospital at 1 site in Denmark.
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 6 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: status not confirmed, as of the sponsor's last update on 23 Jun 2009. 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 Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Ibsen, MD (+ 45 45 35 94 18, micibs@dadlnet.dk), or a site near the patient. 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 23 Jun 2009.