Septic ShockNCT00197938
Lactic Acid in the Rectum and Life-Threatening Infection
An observational study of Septic Shock, run by Herlev Hospital at 5 sites in 2 countries.
Trial summary
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of lactic acid. The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Measurement of rectal lactic acid.
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2005to Apr 2009
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with early septic shock (< 24 h).
Who may be able to join
- Fluid resuscitated septic shock < 24 h.
Who cannot join
- Septic shock > 24 h.
- Pathology in the rectum.
- Bleeding per rectum.
- Limitation of therapy.
- Where informed consent from relatives cannot be obtained.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark4 sites
Dept. of Intensive Care 4131, Rigshospitalet
Copenhagen, DK-2100
Dept. of Intensive Care, Glostrup University Hospital
Glostrup Municipality, DK-2600
Dept. of Intensive Care, Gentofte University Hospital
Hellerup, DK-2900
Dept. of Intensive Care, Herlev University Hospital
Herlev, DK-2730
Finland1 site
Dept. of Intensive Care, Tampere University Hospital
Tampere, 33521
About this study
Official title: Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?
Life-threatening infection impairs bloodflow to the gut, thereby causing less delivery of oxygen. This leads to increased formation of lactic acid.
The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.
- Conditions
- Septic Shock
- Being tested
- 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.
Measurement of rectal lactic acid.Procedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2005
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Anders Perner, MD, PhD, Study chair, Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197938
- Sponsor's protocol ID
- KA 05091m
- Status last verified
- Jun 2009
- First submitted
- 14 Sep 2005
- Last updated
- 9 Jun 2009
- Results posted
- No
Publications
Ibsen M, Tenhunen J, Wiis J, Waldau T, Lauritsen AO, Thornberg K, Joensen H, Perner A. Lactate concentrations in the rectal lumen in patients in early septic shock. Acta Anaesthesiol Scand. 2010 Aug;54(7):827-32. doi: 10.1111/j.1399-6576.2010.02263.x. Epub 2010 Jun 15.
PubMed 20560883
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Concentration of L-Lactate in the Rectum Correlate With Mortality and Morbidity in Patients With Septic Shock?
- ClinicalTrials.gov ID
- NCT00197938
- Acronym / sponsor ID
- KA 05091m
- Conditions
- Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Sep 2005 (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 lactic acid.
The investigators hypothesize, that the more serious the condition, the higher the concentration of lactic acid will be, thus relating to the risk of multiple organ failure or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with early septic shock (< 24 h).
Key inclusion criteria (1 listed)
- Fluid resuscitated septic shock < 24 h.
Key exclusion criteria (5 listed)
- Septic shock > 24 h.
- Pathology in the rectum.
- Bleeding per rectum.
- Limitation of therapy.
- Where informed consent from relatives cannot be obtained.
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 |
|---|---|---|
| Measurement of rectal lactic acid. | Procedure or surgery | – |
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 9 Jun 2009.
- Derived from this study: PubMed 20560883Ibsen M, Tenhunen J, Wiis J, Waldau T, Lauritsen AO, Thornberg K, Joensen H, Perner A. Lactate concentrations in the rectal lumen in patients in early septic shock. Acta Anaesthesiol Scand. 2010 Aug;54(7):827-32. doi: 10.1111/j.1399-6576.2010.02263.x. Epub 2010 Jun 15.
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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.
Anders Perner, MD, PhD study chair
Dept. of Anaesthesia and Intensive Care, Herlev University Hospital, DK-2730 Herlev
5 sites in 2 countries: 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 5 sites in 2 countries.
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 5 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 9 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 5 sites in Denmark, Finland. 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?
On the ClinicalTrials.gov record for NCT00197938, which also lists 1 linked publication.
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 9 Jun 2009.