Severe SepsisPhase 4NCT00484133
Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
A Phase 4 study testing Dopamine, dobutamine and enoximone in people with Severe Sepsis and Microcirculation, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Microcirculation
- What is being tested?
- Dopamine, dobutamine and enoximone
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to Dec 2008
- Phase
- Phase 4
- 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
Who may be able to join
- age 18 years or older
- admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria
- intention to provide full intensive care treatment for at least 72 hours and
- written informed consent to be obtained from patient or next of kin.
Who cannot join
- haematologic malignancy
- metastatic malignancy
- AIDS with CD4 < 50 cells/mm3
- liver cirrhosis Child Pugh B \& C
- pregnancy
- post resuscitation with GCS < 8 of 15 and treatment with induced hypothermia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Onze Lieve Vrouwe Gasthuis, intensive care
Amsterdam, 1090 HM
Rutger v Raalte, MD, 0031205993007, R.vanRaalte@olvg.nl
Rutger v Raalte, MD
About this study
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
Read the detailed description
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.
- Conditions
- Severe Sepsis, Microcirculation
- Being tested
- Dopamine, dobutamine, enoximone, nitroglycerine, noradrenaline
- Keywords
- sepsis, severe sepsis, microcirculation, Orthogonal polarisation spectral
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DopamineDrug
dobutamineDrug
enoximoneDrug
nitroglycerineDrug
noradrenalineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
Measured: 72 hours
Secondary outcomes (6)
Severity, decrease and duration of organ failure over the complete ICU stay
Measured: complete icu stay
Duration of organ support
Measured: during ICU treatment
ICU and hospital length of stay
Measured: hospital stay
ICU and hospital mortality
Measured: hospital stay
Inflammatory response measured by IL-6/IL-10
Measured: 72 hours
Plasma concentration of asymmetric dimethyl arginine (ADMA
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2008 (estimated)
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 Severe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Investigators
- Rutger v Raalte, MD, Principal investigator, Onze Lieve Vrouwe Gasthuis, intensive care unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484133
- Sponsor's protocol ID
- WO-06.068
- Status last verified
- Jan 2008
- First submitted
- 6 Jun 2007
- Last updated
- 22 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.
PubMed 25032942
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
- ClinicalTrials.gov ID
- NCT00484133
- Acronym / sponsor ID
- WO-06.068
- Conditions
- Severe Sepsis, Microcirculation
- Keywords
- sepsis, severe sepsis, microcirculation, Orthogonal polarisation spectral
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2008 (estimated)
- First posted
- 8 Jun 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.
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
Detailed description
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older
- admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria
- intention to provide full intensive care treatment for at least 72 hours and
- written informed consent to be obtained from patient or next of kin.
Key exclusion criteria (6 listed)
- haematologic malignancy
- metastatic malignancy
- AIDS with CD4 < 50 cells/mm3
- liver cirrhosis Child Pugh B \& C
- pregnancy
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 |
|---|---|---|
| Dopamine | Drug | – |
| dobutamine | Drug | – |
| enoximone | Drug | – |
| nitroglycerine | Drug | – |
| noradrenaline | Drug | – |
Primary outcome
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
Time frame: 72 hours
6 secondary outcomes
Severity, decrease and duration of organ failure over the complete ICU stay
Time frame: complete icu stay
Duration of organ support
Time frame: during ICU treatment
ICU and hospital length of stay
Time frame: hospital stay
ICU and hospital mortality
Time frame: hospital stay
Inflammatory response measured by IL-6/IL-10
Time frame: 72 hours
Plasma concentration of asymmetric dimethyl arginine (ADMA
Time frame: 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2008.
- Derived from this study: PubMed 25032942van der Voort PH, van Zanten M, Bosman RJ, van Stijn I, Wester JP, van Raalte R, Oudemans-van Straaten HM, Zandstra DF. Testing a conceptual model on early opening of the microcirculation in severe sepsis and septic shock: a randomised controlled pilot study. Eur J Anaesthesiol. 2015 Mar;32(3):189-98. doi: 10.1097/EJA.0000000000000126.
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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.
Rutger v Raalte, MD principal investigator
Onze Lieve Vrouwe Gasthuis, intensive care unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dopamine, dobutamine and enoximone in people with Severe Sepsis and Microcirculation, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
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 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 22 Jan 2008. 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 Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rutger v Raalte, MD (0031205993007, R.vanRaalte@olvg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis (time frame: 72 hours). 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 NCT00484133, 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 22 Jan 2008.