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

Study Overview
=================
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%.

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

Conditions
-----------------
Shock, Septic

Intervention / Treatment
-----------------
* Procedure: Passive Leg Raising Test
* Procedure: Standard of care


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive Leg Raising<br>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<br>* 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.<br>|
| Active Comparator: Standard of care<br>Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician. | Procedure: Standard of care<br>* Patients are treated according to Surviving Sepsis Guidelines<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight gain |  | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | measured within 90 days after inclusion | 
| Cumulative fluid balance study day 1,2,3 | Fluids in-Fluids out during the study period. | Study day 1,2,3 | 
| 30 day mortality | Is the patient alive or dead after 30 days? | 30 days from inclusion in the study | 
| Organ support during ICU stay | Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT. | ICU-stay | 
| ICU discharge status | Alive or dead at discharge from the ICU? | End of ICU stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shock, septic, hemodynamics, algorithms