Septic ShockNCT01827007
Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
A study testing Volume expansion with gelofusine in people with Septic Shock, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Volume expansion with gelofusine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Feb 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
- Contraindication to fluid challenge
- Contraindication to TEE
- Previous heart failure, heart valve stenosis of insufficiency
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.
- Conditions
- Septic Shock
- Being tested
- Volume expansion with gelofusine
- Keywords
- norepinephrine infusion, under 48 hours in ICU
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume expansion with gelofusineOther
| Study group | Role | What they receive |
|---|---|---|
| Study arm, elevation of PEEP | Experimental | Not described Receives: Other: Volume expansion with gelofusine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.
Measurement of hemodynamic variables using a pulmonary catheter and transesophageal echocardiography at baseline PEEP 10, during elevation of PEEP and after volume challenge at PEEP 10 cmH2O
Measured: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes
Secondary outcomes (1)
Pulmonary function and oxygenation
Measured: 0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2012
- Study completionFeb 2013
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.
- More trials run by Helsinki University Central HospitalThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erika Wilkman, Helsinki University Central Hospital
- Investigators
- Erika Wilkman, M.D, Principal investigator, Anesthesia and Intensive Care, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01827007
- Sponsor's protocol ID
- HUS469/E6/05
- Status last verified
- Apr 2013
- First submitted
- 2 Apr 2013
- Last updated
- 9 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fluid Responsiveness by Elevation of PEEP in Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT01827007
- Acronym / sponsor ID
- HUS469/E6/05
- Conditions
- Septic Shock
- Keywords
- norepinephrine infusion, under 48 hours in ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Apr 2013 (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 aim of the study is to evaluate whether fluid responsiveness of the critically ill patient can be assessed by analysing the PEEP-induced hemodynamic effects to systolic blood pressure, pulse pressure, aortic blood flow, aortic time-velocity integral and left ventricular end diastolic area measured with transesophageal echocardiography (PEEP-test). The chances are compared to increase of CI after volume expansion (gold standard). In clinical practise, it would be especially relevant if PEEP-induced changes in arterial pressure variations could be used in evaluation of volume status and fluid responsiveness. However, as ECHO-derived variables are used in greater extent to guide the treatment with inappropriate evidence, the simultaneous registration of ECHO-derived hemodynamic measurements is essential in the study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study arm, elevation of PEEP | Experimental | Other: Volume expansion with gelofusine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Contraindication to elevation of PEEP ( elevated intracranial pressure, pulmonary hypertension or other contraindication )
- Contraindication to fluid challenge
- Contraindication to TEE
- Previous heart failure, heart valve stenosis of insufficiency
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 |
|---|---|---|
| Volume expansion with gelofusine | Other | Study arm, elevation of PEEP |
Primary outcome
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral.
Time frame: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes
Measurement of hemodynamic variables using a pulmonary catheter and transesophageal echocardiography at baseline PEEP 10, during elevation of PEEP and after volume challenge at PEEP 10 cmH2O
1 secondary outcome
Pulmonary function and oxygenation
Time frame: 0,10,20,60 minutes, at PEEP 10, 20,10 cmH2O and after fluid expansion PEEP10 cmH2O
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 Apr 2013.
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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.
Erika Wilkman, M.D principal investigator
Anesthesia and Intensive Care, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume expansion with gelofusine in people with Septic Shock, run by Helsinki University Central Hospital at 1 site in Finland.
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 0 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 9 Apr 2013. 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 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.
What does the primary outcome measure?
Hemodynamic changes indicating fluid responsiveness assessed during elevation of PEEP. Change in mean arterial pressure or aortic velocity time integral. (time frame: Measurement of hemodynamic variables at timepoints 0, 10,20, 60 minutes). It is what the study was designed to measure, not a finding.
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 9 Apr 2013.