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

Septic Shock Clinical Trial

— MICRORESUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03898674
• Other study ID #: 40180
• Status: Recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2019
• Source: King's College London
• Contact: Sam Hutchings, PhD
• Phone: 07832678654
• Email: sam.hutchings[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Intra venous fluid
Volume of intra venous fluid administered during GDT protocol

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to acquire POEM score	Feasibility measure of point of care test	6 hours
Primary	Effect of POEM score on clinical decision making	Feasibility outcome measure	6 hours