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

Shock, Septic Clinical Trial

— OFTaPLR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02301585
• Other study ID #: PLR EPN 2013/1337-31/2
• Status: Terminated
• Phase: N/A
• First received: September 14, 2014
• Last updated: February 8, 2016
• Start date: February 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shock, Septic

Intervention

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.
• Standard of care
Patients are treated according to Surviving Sepsis Guidelines

Locations

Country	Name	City	State
Sweden	Karolinska Institutet Södersjukhuset	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden, Svenska militärläkarföreningen

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain		3 days	No
Secondary	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	No
Secondary	Cumulative fluid balance study day 1,2,3	Fluids in-Fluids out during the study period.	Study day 1,2,3	No
Secondary	30 day mortality	Is the patient alive or dead after 30 days?	30 days from inclusion in the study	No
Secondary	Organ support during ICU stay	Number of days with mechanical ventilation, vasopressors/inotropic support, CRRT.	ICU-stay	No
Secondary	ICU discharge status	Alive or dead at discharge from the ICU?	End of ICU stay	No