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

Karolinska Institutet34 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Shock, Septic

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

weight gain

Time frame: 3 days

Secondary Outcomes

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