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

December 7, 2018 updated by: King's College London

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with early septic shock admitted to ICU

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
KDIGO AKI grade
Time Frame: Day 7
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Royal Centre for Defence Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2018

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

October 18, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 246076

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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