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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
Sponsor:
Collaborators:
Stockholm County Council, Sweden
Svenska militärläkarföreningen
Information provided by (Responsible Party):
Christer Svensen, Karolinska Institutet

Brief 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. 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. weight gain [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. 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.

  2. Cumulative fluid balance study day 1,2,3 [ Time Frame: Study day 1,2,3 ]
    Fluids in-Fluids out during the study period.

  3. 30 day mortality [ Time Frame: 30 days from inclusion in the study ]
    Is the patient alive or dead after 30 days?

  4. Organ support during ICU stay [ Time Frame: ICU-stay ]
    Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.

  5. ICU discharge status [ Time Frame: End of ICU stay ]
    Alive or dead at discharge from the ICU?



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

> 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.


Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska Institutet Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Svenska militärläkarföreningen
Investigators
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Principal Investigator: Christer Svensen, Prof Karolinska Institutet

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Responsible Party: Christer Svensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02301585     History of Changes
Other Study ID Numbers: PLR EPN 2013/1337-31/2
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Keywords provided by Christer Svensen, Karolinska Institutet:
shock, septic
hemodynamics
algorithms

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation