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

Karolinska Institute

Status: Terminated

Conditions: Shock, Septic

Treatments: Procedure: Passive Leg Raising Test; Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT02301585

PLR EPN 2013/1337-31/2

Details and patient eligibility

About

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%.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

34 participants in 2 patient groups

Passive Leg Raising

Experimental group

Description:

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.

Treatment:

Procedure: Passive Leg Raising Test

Standard of care

Active Comparator group

Description:

Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.

Treatment:

Procedure: Standard of care