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Clinical Trials/NCT03898674
NCT03898674
Unknown
Not Applicable

Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study

King's College London1 site in 1 country30 target enrollmentFebruary 5, 2019

Overview

Phase
Not Applicable
Intervention
Intra venous fluid
Conditions
Septic Shock
Sponsor
King's College London
Enrollment
30
Locations
1
Primary Endpoint
Time to acquire POEM score
Last Updated
7 years ago

Overview

Brief Summary

Prospective single centre study to assess the feasibility of fluid resuscitation guided by macrocirculatory and microcirculation parameters in patients in the early stages of septic shock. The investigators will utilise a novel point of care tool to assess microcirculatory sublingual perfusion in patients with septic shock. This, in combination with conventional haemodynamic monitoring will determine the timing and volume of resuscitative fluid administration. The feasibility of this technique will be determined prior to embarking on a pilot RCT.

Registry
clinicaltrials.gov
Start Date
February 5, 2019
End Date
October 1, 2020
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years Within 6 hours of ICU admission Evidence of suspected or confirmed infection Serial Organ Failure Assessment (SOFA) score increase of 2 or more (assuming baseline 0 if no previous measures) Requiring vasopressor therapy to maintain a MAP \> 65mmHg Lactate \> 2 mmol/l despite initial fluid resuscitation Requirement for advanced haemodynamic monitoring (PiCCO system) in the opinion of the attending clinician

Exclusion Criteria

  • Patients not expected to survive 24 h in whom the intent of treatment is palliative Patients in whom the primary cause of the shock state is cardiogenic

Arms & Interventions

GDT feasibility

Patients undergoing microcirculatory goal directed therapy

Intervention: Intra venous fluid

Outcomes

Primary Outcomes

Time to acquire POEM score

Time Frame: 6 hours

Feasibility measure of point of care test

Effect of POEM score on clinical decision making

Time Frame: 6 hours

Feasibility outcome measure

Study Sites (1)

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