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

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ClinicalTrials.gov Identifier: NCT03898674
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Intra venous fluid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Feasibility study - single arm
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Microcirculatory Guided Goal Directed Fluid Therapy in Septic Shock; a Feasibility Study
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: GDT feasibility
Patients undergoing microcirculatory goal directed therapy
Drug: Intra venous fluid
Volume of intra venous fluid administered during GDT protocol




Primary Outcome Measures :
  1. Time to acquire POEM score [ Time Frame: 6 hours ]
    Feasibility measure of point of care test

  2. Effect of POEM score on clinical decision making [ Time Frame: 6 hours ]
    Feasibility outcome measure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03898674


Contacts
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Contact: Sam Hutchings, PhD 07832678654 sam.hutchings@nhs.net

Locations
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United Kingdom
King's College Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Contact: Sam Hutchings, PhD       sam.hutchings@nhs.net   
Sponsors and Collaborators
King's College London

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03898674     History of Changes
Other Study ID Numbers: 40180
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation