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

NCT03713307 | Unknown

• 1 other identifier: 246076
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Septic Shock

Keywords

Septic shock; acute kidney injury; haemodynamic monitoring; microcirculation

Outcome Measures

Primary Outcomes (1)

• KDIGO AKI grade

  Day 7

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with early septic shock admitted to ICU

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Royal Centre for Defence Medicine: collaborator

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• Watchorn J, Huang D, Bramham K, Hutchings S. Decreased renal cortical perfusion, independent of changes in renal blood flow and sublingual microcirculatory impairment, is associated with the severity of acute kidney injury in patients with septic shock. Crit Care. 2022 Sep 1;26(1):261. doi: 10.1186/s13054-022-04134-6.

  PMID: 36050737 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, plasma, serum, urine

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Central Study Contacts

Sam Hutchings, PhD

CONTACT

0203286000; sam.hutchings@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 19, 2018
• Study Start: November 27, 2018
• Primary Completion: June 1, 2020
• Study Completion: November 1, 2020
• Last Updated: December 10, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)