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

NCT03898674 | Unknown

• 1 other identifier: 40180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (2)

• Time to acquire POEM score

  Feasibility measure of point of care test

  6 hours

• Effect of POEM score on clinical decision making

  Feasibility outcome measure

  6 hours

Study Arms (1)

GDT feasibility

EXPERIMENTAL

Patients undergoing microcirculatory goal directed therapy

Drug: Intra venous fluid

Interventions

Intra venous fluid DRUG

Volume of intra venous fluid administered during GDT protocol

GDT feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Sam Hutchings, PhD

CONTACT

07832678654; sam.hutchings@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility study - single arm

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: April 2, 2019
• Study Start: February 5, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)