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

NCT02301585 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-02-09

No results posted yet for this study

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

Interventions

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.

PROCEDURE

Standard of care

Patients are treated according to Surviving Sepsis Guidelines

Sponsors & Collaborators

  • Region Stockholm

    collaborator OTHER_GOV

  • Svenska militärläkarföreningen

    collaborator UNKNOWN

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Christer Svensen, Prof · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02301585 on ClinicalTrials.gov