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Resuscitation Strategies in Septic Shock

NCT02150512 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2014-11-21

No results posted yet for this study

Summary

The purpose of this study, in mechanically ventilated septic shock patients, is to determine whether a fluid loading strategy based on parameters derived from the transpulmonary thermodilution technique may lead to more ventilator free days compared to a fluid loading strategy based on the surviving sepsis guidelines.

Conditions

  • Septic Shock
  • Critically Ill

Interventions

DEVICE

Transpulmonary Thermodilution

Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. If SVV ≤10% in patients on controlled mechanical ventilation with tidal volumes of ≥8 ml/kg, fluid loading will not be performed. If SVV \>10% or spontaneous breathing efforts are present, a fluid challenge should be performed. Also if patients are on controlled mechanical ventilation with tidal volumes of ≤7 ml/kg, a fluid challenge should be performed. If fluid responsiveness is present and SVV decreases to ≤10%, further fluid loading should be stopped. If SVV is still \>10%, the increase in EVLW will decide whether to continue fluid loading or not; if EVLW is ≥12 mL/kg PBW and EVLW increases upon fluid loading, further fluid loading should be stopped.

DEVICE

Surviving Sepsis Guidelines (SSG)

Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). If circulatory insufficiency is absent, fluid loading will not be initiated or stopped independently of the actual CVP level.

Sponsors & Collaborators

  • Medisch Spectrum Twente

    lead OTHER

Principal Investigators

  • RJ Trof, MD PhD · Medisch Spectrum Twente, department of Intensive Care

  • A Beishuizen, MD PhD · Medisch Spectrum Twente, department of Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • Netherlands

Study Locations

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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 NCT02150512 on ClinicalTrials.gov