Shock, SepticOFTaPLRNCT02301585
Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test
A study testing Passive Leg Raising Test in people with Shock, Septic, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Septic
- What is being tested?
- Passive Leg Raising Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2014to Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients >18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.
Who cannot join
- > 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure>20 cm H2O.
- Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding.
- Serious adverse events:
- Trombosis in arteria femoralis. Death during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU
A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department.
Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.
- Conditions
- Shock, Septic
- Being tested
- Passive Leg Raising Test, Standard of care
- Keywords
- shock, septic, hemodynamics, algorithms
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg Raising TestProcedure or surgery
Before decision on fluid administration a passive leg raising test is performed. The results are interpreted according to a treatment protocol. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.
Standard of careProcedure or surgery
Patients are treated according to Surviving Sepsis Guidelines
| Study group | Role | What they receive |
|---|---|---|
| Passive Leg Raising | Experimental | Before decision on fluid administration a passive leg raising test is performed. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes. Receives: Procedure: Passive Leg Raising Test |
| Standard of care | Active comparator | Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician. Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 3 days
Secondary outcomes (5)
ICU length of stay
Number of days spent in the ICU: time and date of discharge from the ICU minus time and date of admission to the ICU. A started but not yet completed day is counted as one.
Measured: measured within 90 days after inclusion
Cumulative fluid balance study day 1,2,3
Fluids in-Fluids out during the study period.
Measured: Study day 1,2,3
30 day mortality
Is the patient alive or dead after 30 days?
Measured: 30 days from inclusion in the study
Organ support during ICU stay
Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.
Measured: ICU-stay
ICU discharge status
Alive or dead at discharge from the ICU?
Measured: End of ICU stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Why it stopped: The study was stopped because of futility due to unexpected low weight gain in both groups.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shock, SepticStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Svenska militärläkarföreningen
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Christer Svensen, Prof, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301585
- Sponsor's protocol ID
- PLR EPN 2013/1337-31/2
- Acronym
- OFTaPLR
- Status last verified
- Feb 2016
- First submitted
- 14 Sep 2014
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU
- ClinicalTrials.gov ID
- NCT02301585
- Acronym / sponsor ID
- OFTaPLR / PLR EPN 2013/1337-31/2
- Conditions
- Shock, Septic
- Keywords
- shock, septic, hemodynamics, algorithms
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of futility due to unexpected low weight gain in both groups.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Svenska militärläkarföreningen
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 26 Nov 2014 (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.
A randomized controlled clinical trial to evaluate whether a passive leg raising test to guide fluid therapy of patients with septic shock can reduce fluid balance and weight gain. Patients will be treated according to an algorithm in which the indexed stroke volume (stroke volume related to body surface area) and mean arterial pressure will guide the timing and amount of fluid and the use of inotropic and vasoactive support. Patients will be randomized to either an intervention group in which a passive leg raising test will be made prior to any decision for fluid administration or to a control group where this test is not performed and fluid administration is carried out according to standard of care at the department.
Hypothesis: A passive leg raising test, will reduce weight gain by day 3 by 30%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Leg Raising | Experimental | Procedure: Passive Leg Raising TestBefore decision on fluid administration a passive leg raising test is performed. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes. |
| Standard of care | Active comparator | Procedure: Standard of carePatients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients >18 years admitted to the ICU diagnosed with circulatory shock due to suspected sepsis or pancreatitis. Circulatory shock is defined as MAP<70 mm Hg or need for norepinephrine despite resuscitation with ≥30 ml/kg of crystalloid fluids.
Key exclusion criteria (4 listed)
- > 12 hours have passed after onset of shock. The patient has contraindications for an arterial femoral/axillary line. Elevated ICP. Patients who have had a femoral amputation. Elevated intraabdominal pressure>20 cm H2O.
- Suspension criteria: The patient has developed pulmonary oedema during PLR test. Life threatening bleeding.
- Trombosis in arteria femoralis. Death during the study period.
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 |
|---|---|---|
| Passive Leg Raising TestBefore decision on fluid administration a passive leg raising test is performed. The results are interpreted according to a treatment protocol. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes. | Procedure or surgery | Passive Leg Raising |
| Standard of carePatients are treated according to Surviving Sepsis Guidelines | Procedure or surgery | Standard of care |
Primary outcome
weight gain
Time frame: 3 days
5 secondary outcomes
ICU length of stay
Time frame: measured within 90 days after inclusion
Cumulative fluid balance study day 1,2,3
Time frame: Study day 1,2,3
30 day mortality
Time frame: 30 days from inclusion in the study
Organ support during ICU stay
Time frame: ICU-stay
ICU discharge status
Time frame: End of ICU stay
Results and safety
The study was stopped early (reason given: The study was stopped because of futility due to unexpected low weight gain in both groups.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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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.
Christer Svensen, Prof principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raising Test in people with Shock, Septic, run by Karolinska Institutet at 1 site in Sweden.
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 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: stopped early, as of the sponsor's last update on 9 Feb 2016. 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 Sweden. 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 was stopped early (reason given: The study was stopped because of futility due to unexpected low weight gain in both groups.). Results are not available in the source record.
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?
weight gain (time frame: 3 days). 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 Feb 2016.