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

NCT02301585 | Terminated DMC

• 1 other identifier: PLR EPN 2013/1337-31/2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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%.

Conditions

Shock, Septic

Keywords

shock, septic; hemodynamics; algorithms

Outcome Measures

Primary Outcomes (1)

• weight gain

  3 days

Secondary Outcomes (5)

• ICU length of stay

  measured within 90 days after inclusion

• Cumulative fluid balance study day 1,2,3

  Study day 1,2,3

• 30 day mortality

  30 days from inclusion in the study

• Organ support during ICU stay

  ICU-stay

• ICU discharge status

  End of ICU stay

Study Arms (2)

Passive Leg Raising

EXPERIMENTAL

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

Standard of care

ACTIVE COMPARATOR

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

Procedure: Standard of care

Interventions

Passive Leg Raising Test PROCEDURE

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.

Passive Leg Raising

Standard of care PROCEDURE

Patients are treated according to Surviving Sepsis Guidelines

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Svenska militärläkarföreningen: collaborator

Study Sites (1)

Karolinska Institutet Södersjukhuset

Stockholm, 11883, Sweden

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Christer Svensen, Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2014
• First Posted: November 26, 2014
• Study Start: February 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

SE (1)