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

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

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 Overview

• Status: Terminated
• Conditions: Shock, Septic
• Intervention / Treatment: Procedure: Passive Leg Raising Test; Procedure: Standard of care

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 11883
    • Karolinska institutet södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm; Svenska militärläkarföreningen
• Investigators: Principal Investigator: Christer Svensen, Prof, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: September 14, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): November 26, 2014

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: hemodynamics; algorithms; shock, septic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: PLR EPN 2013/1337-31/2