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

Primary Purpose

Septic Shock

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Intra venous fluid

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

King's College Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GDT feasibility

Arm Description

Patients undergoing microcirculatory goal directed therapy

Outcomes

Primary Outcome Measures

Time to acquire POEM score

Feasibility measure of point of care test

Effect of POEM score on clinical decision making

Feasibility outcome measure

Secondary Outcome Measures

Full Information

NCT ID

NCT03898674

First Posted

March 22, 2019

Last Updated

March 29, 2019

Sponsor

King's College London

1. Study Identification

Unique Protocol Identification Number

NCT03898674

Brief Title

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

Acronym

MICRORESUS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 5, 2019 (Actual)

Primary Completion Date

October 1, 2020 (Anticipated)

Study Completion Date

October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Feasibility study - single arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GDT feasibility

Arm Type

Experimental

Arm Description

Patients undergoing microcirculatory goal directed therapy

Intervention Type

Drug

Intervention Name(s)

Intra venous fluid

Intervention Description

Volume of intra venous fluid administered during GDT protocol

Primary Outcome Measure Information:

Title

Time to acquire POEM score

Description

Feasibility measure of point of care test

Time Frame

6 hours

Title

Effect of POEM score on clinical decision making

Description

Feasibility outcome measure

Time Frame

6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sam Hutchings, PhD

Phone

07832678654

sam.hutchings@nhs.net

Facility Information:

Facility Name

King's College Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sam Hutchings, PhD

sam.hutchings@nhs.net

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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