Septic ShockNCT01013662
Lipid Profile in Patients With Severe Sepsis or Septic Shock Under Strict or Liberal Glycemic Control
A study of Septic Shock and Sepsis, run by University of Sao Paulo.
Trial summary
Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU. Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Sepsis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Jul 2007
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients aged between 18 and 80 years old
- with the diagnostic of septic shock or severe sepsis
Who cannot join
- pregnants,
- previous diagnosis of any cancer,
- diagnosis of leptospirosis,
- diagnosis of aids.
About this study
Official title: Tight Glycemic Control and Sepsis Related Dyslipidemia
Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU.
Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin
Read the detailed description
The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and divided them in two different groups after randomization with sealed envelopes.
One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl with exogenous insulin.
The other group called conventional glycemic control with glycemic levels been between 180 and 220 mg/dl.
Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total cholesterol, free fatty acids and oxidized LDL.
Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood gasometry were either monitored.
- Conditions
- Septic Shock, Sepsis
- Being tested
- glycemic control
- Keywords
- septic shock, glycemic control, icu, lipid metabolism, septic patients
- Medical subject headings
- Shock, Septic, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycemic controlProcedure or surgery
exogenous insulin
| Study group | Role | What they receive |
|---|---|---|
| glycemic control between 180 and 220 mg/dl | Active comparator | Not described Receives: Procedure: glycemic control |
| glycemic control for levels between 80 and 110 mg/dl | Active comparator | Not described Receives: Procedure: glycemic control |
What is being measured
The primary outcome is the main question the study is designed to answer.
establish a relationship between lipid metabolism alterations and glycemic control
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2009 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionJul 2007
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.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01013662
- Sponsor's protocol ID
- scap1501
- Status last verified
- Nov 2009
- First submitted
- 13 Nov 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cappi SB, Noritomi DT, Velasco IT, Curi R, Loureiro TC, Soriano FG. Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis. Intensive Care Med. 2012 Apr;38(4):634-41. doi: 10.1007/s00134-011-2458-z. Epub 2012 Feb 2.
PubMed 22297666
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tight Glycemic Control and Sepsis Related Dyslipidemia
- ClinicalTrials.gov ID
- NCT01013662
- Acronym / sponsor ID
- scap1501
- Conditions
- Septic Shock, Sepsis
- Keywords
- septic shock, glycemic control, icu, lipid metabolism, septic patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 16 Nov 2009 (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.
Study of the lipid metabolism under glycemic control in septic patients who got an university 14 bed ICU.
Hypothesis: establish a relationship between lipid metabolism alterations and glycemic control or infusion of exogenous insulin
Detailed description
The investigators enrolled 69 consecutive patients with severe sepsis or septic shock and divided them in two different groups after randomization with sealed envelopes.
One group called intensive glycemic control with glycemic levels been between 80 to 110 mg/dl with exogenous insulin.
The other group called conventional glycemic control with glycemic levels been between 180 and 220 mg/dl.
Blood samples were collected at 0, 12, 24, 48 and 72 hours to measure HDL, LDL, Total cholesterol, free fatty acids and oxidized LDL.
Clinical data as creatinine, P/F ratio, bilirubins, platelets, lactate, arterial blood gasometry were either monitored.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glycemic control between 180 and 220 mg/dl | Active comparator | Procedure: glycemic control |
| glycemic control for levels between 80 and 110 mg/dl | Active comparator | Procedure: glycemic control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- all patients aged between 18 and 80 years old
- with the diagnostic of septic shock or severe sepsis
Key exclusion criteria (4 listed)
- pregnants,
- previous diagnosis of any cancer,
- diagnosis of leptospirosis,
- diagnosis of aids.
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 |
|---|---|---|
| glycemic controlexogenous insulin | Procedure or surgery | glycemic control between 180 and 220 mg/dl, glycemic control for levels between 80 and 110 mg/dl |
Primary outcome
establish a relationship between lipid metabolism alterations and glycemic control
Time frame: 2 years
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 4 Aug 2011.
- Derived from this study: PubMed 22297666Cappi SB, Noritomi DT, Velasco IT, Curi R, Loureiro TC, Soriano FG. Dyslipidemia: a prospective controlled randomized trial of intensive glycemic control in sepsis. Intensive Care Med. 2012 Apr;38(4):634-41. doi: 10.1007/s00134-011-2458-z. Epub 2012 Feb 2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study of Septic Shock and Sepsis, run by University of Sao Paulo.
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 2 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: finished, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
establish a relationship between lipid metabolism alterations and glycemic control (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01013662, 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 4 Aug 2011.