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Trial record 8 of 32 for:    shock | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

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

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ClinicalTrials.gov Identifier: NCT03713307
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : December 10, 2018
Sponsor:
Collaborator:
Royal Centre for Defence Medicine
Information provided by (Responsible Party):
King's College London

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
Acute Kidney Injury Septic Shock

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Study Type : Observational
Estimated 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 : November 27, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock




Primary Outcome Measures :
  1. KDIGO AKI grade [ Time Frame: Day 7 ]

Biospecimen Retention:   Samples Without DNA
Blood, plasma, serum, urine


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
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with early septic shock admitted to ICU
Criteria

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


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): NCT03713307


Contacts
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Contact: Sam Hutchings, PhD 0203286000 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
Royal Centre for Defence Medicine

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03713307     History of Changes
Other Study ID Numbers: 246076
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: October 2018
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
Keywords provided by King's College London:
Septic shock
acute kidney injury
haemodynamic monitoring
microcirculation
Additional relevant MeSH terms:
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Shock, Septic
Acute Kidney Injury
Shock
Renal Insufficiency
Kidney Diseases
Pathologic Processes
Urologic Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation