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Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic - MICROSHOCK - RENAL

Sponsor
King's College London (Other)
Overall Status
Unknown status
CT.gov ID
NCT03713307
Collaborator
Royal Centre for Defence Medicine (Other)
50
Enrollment
1
Location
23.2
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An observational study of the state of the renal and systemic circulations in patients with early septic shock. Both macro and microvascular parameters will be assessed using echocardiography, sublingual incident dark field video-microscopy and renal contrast enhanced ultrasound. Patients will be categorised by KDIGO degree of kidney injury at Day 7 and stratified. Haemodynamic and perfusion based variables over time for these groups will be compared to assess the impact of changes in same on the development of AKI. Lab based work to quantify renal injury biomarkers will also be undertaken.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic Circulations; a Prospective Observational Study
    Actual Study Start Date :
    Nov 27, 2018
    Anticipated Primary Completion Date :
    Jun 1, 2020
    Anticipated Study Completion Date :
    Nov 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. KDIGO AKI grade [Day 7]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    Age > 18 years Within 48 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

    Exclusion Criteria:

    Known intolerance to Sonovue or any other ultrasound contrast agent Acute Respiratory Distress Syndrome Pregnancy Breast Feeding mothers Patients not expected to survive 24 h in whom the intent of treatment is palliative

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 King's College Hospital NHS Foundation Trust London United Kingdom SE5 9RS

    Sponsors and Collaborators

    • King's College London
    • Royal Centre for Defence Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    King's College London
    ClinicalTrials.gov Identifier:
    NCT03713307
    Other Study ID Numbers:
    • 246076
    First Posted:
    Oct 19, 2018
    Last Update Posted:
    Dec 10, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by King's College London
    Septic shock
    acute kidney injury
    haemodynamic monitoring
    microcirculation
    Additional relevant MeSH terms:
    Shock, Septic
    Acute Kidney Injury
    Shock

    Study Results

    No Results Posted as of Dec 10, 2018