An interventional study of Passive Leg Raising Test and Standard of care in Shock, Septic, sponsored by Karolinska Institutet. Terminated at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-09.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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%.
890 studies on the registry are indexed under Shock, Septic; 210 are open to participants now.
This study's enrollment of 34 is below the median of 78 across 547 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Karolinska Institutet is the lead sponsor of 1,145 studies on the registry; 274 are open to participants now.
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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.
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
Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.
Procedure: Standard of care
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.
Patients are treated according to Surviving Sepsis Guidelines
weight gain
Time frame: 3 days
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.
Time frame: measured within 90 days after inclusion
Cumulative fluid balance study day 1,2,3
Fluids in-Fluids out during the study period.
Time frame: Study day 1,2,3
30 day mortality
Is the patient alive or dead after 30 days?
Time frame: 30 days from inclusion in the study
Organ support during ICU stay
Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.
Time frame: ICU-stay
ICU discharge status
Alive or dead at discharge from the ICU?
Time frame: End of ICU stay
The record gives a start of Feb 2014, a primary completion of Feb 2016 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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