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

Not Applicable

Terminated

• Conditions: Shock, Septic
• Interventions: Procedure: Standard of care; Procedure: Passive Leg Raising Test

• Registration Number: NCT02301585
• Lead Sponsor: Karolinska Institutet

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 Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-09-14
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	Standard of care	Patients are treated according to Surviving Sepsis Guidelines. Fluid is administered according to the choice of the clinician.
Passive Leg Raising	Passive Leg Raising Test	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.

Primary Outcome Measures

Name	Time	Method
weight gain	3 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karolinska Institutet Södersjukhuset; 🇸🇪 Stockholm, Sweden