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NCT03713307 Clinical Trial

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

Acute Kidney Injury Clinical Trial

Official title:
Macro and Micro Haemodynamic Responses to Shock in the Renal and Systemic Circulations; a Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03713307
Other study ID # 246076
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 27, 2018
Est. completion date November 2020

Study information
Verified date October 2018
Source King's College London
Contact Sam Hutchings, PhD
Phone 0203286000
Email sam.hutchings@nhs.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date November 2020
Est. primary completion date June 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom King's College Hospital NHS Foundation Trust London

Sponsors (2)
Lead Sponsor Collaborator
King's College London Royal Centre for Defence Medicine

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary KDIGO AKI grade Day 7
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