Clinical Trial: Optimization of Fluid Therapy in Sepsis by a Passive Leg Raising Test

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Optimization of Fluid Therapy by a Passive Leg Raising Test in Patients With Septic Shock in the ICU

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%.


Detailed Summary:
Sponsor: Karolinska Institutet

Current Primary Outcome: weight gain [ Time Frame: 3 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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?


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: September 14, 2014
Date Started: February 2014
Date Completion:
Last Updated: February 8, 2016
Last Verified: February 2016