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

Not Applicable

• Conditions: Septic Shock
• Interventions: Drug: Intra venous fluid

• Registration Number: NCT03898674
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Status Verified: 2019-03
• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-02
• Last Update Posted: 2019-04-02
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GDT feasibility	Intra venous fluid	Patients undergoing microcirculatory goal directed therapy

Primary Outcome Measures

Name	Time	Method
Time to acquire POEM score	6 hours	Feasibility measure of point of care test
Effect of POEM score on clinical decision making	6 hours	Feasibility outcome measure

Trial Locations

Locations (1)

King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom