Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test (OFTaPLR)
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|ClinicalTrials.gov Identifier: NCT02301585|
Recruitment Status : Terminated (The study was stopped because of futility due to unexpected low weight gain in both groups.)
First Posted : November 26, 2014
Last Update Posted : February 9, 2016
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%.
|Condition or disease||Intervention/treatment||Phase|
|Shock, Septic||Procedure: Passive Leg Raising Test Procedure: Standard of care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||February 2016|
|Actual Study Completion Date :||February 2016|
Experimental: Passive Leg Raising
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.
Procedure: Passive Leg Raising Test
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.
Active Comparator: Standard of care
Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.
Procedure: Standard of care
Patients are treated according to Surviving Sepsis Guidelines
- weight gain [ Time Frame: 3 days ]
- ICU length of stay [ Time Frame: measured within 90 days after inclusion ]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.
- Cumulative fluid balance study day 1,2,3 [ Time Frame: Study day 1,2,3 ]Fluids in-Fluids out during the study period.
- 30 day mortality [ Time Frame: 30 days from inclusion in the study ]Is the patient alive or dead after 30 days?
- Organ support during ICU stay [ Time Frame: ICU-stay ]Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.
- ICU discharge status [ Time Frame: End of ICU stay ]Alive or dead at discharge from the ICU?
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301585
|Karolinska Institutet Södersjukhuset|
|Stockholm, Sweden, 11883|
|Principal Investigator:||Christer Svensen, Prof||Karolinska Institutet|