Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness

NCT05580367 | Unknown

• 1 other identifier: RHM CRI0428
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Survivors of critical illness commonly experience long-lasting cognitive, mental health and physical impairments. Clinically significant symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) may occur in 40%, 34% and 20% of ICU survivors respectively, compared to 6%, 8% and 4% in the general population. These symptoms can persist for more than 8 years. Evidence shows the existence of a two-way, communication network between gut microbes and the brain referred to as the gut-brain axis. Changes in the microbiome and dysregulation of this communication network in relatively healthy people is associated with cognitive dysfunction and mood disorders such as anxiety and depression. The physiological stress associated with critical illness itself and many ICU interventions including the use of mechanical ventilation and medications such as antibiotics, antacids, vasopressors, and steroids can influence the balance of the gut microbiome and associated metabolites. This observation study aims to:

1. 1.Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery.
2. 2.Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.

Conditions

Mental Health Issue; Critical Illness; Gut Microbiome

Outcome Measures

Primary Outcomes (4)

• Gut microbiome changes

  Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. (The number and diversity of microbe present)

  3 months post-discharge

• Microbiome, metabolic changes and psychological symptoms

  Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery.

  3 months post-discharge

• Gut microbial and metabolic signatures

  Investigate the potential for gut microbial and metabolic signatures at admission and discharge to predict the future development of psychological symptoms following ICU discharge.

  3 months post-discharge

• Sample repository

  Establish a sample repository for future analysis for future studies.

  3 months post-discharge

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an unplanned admission to critical care who are mechanically ventilated

You may qualify if:

• Unplanned admission to critical care
• Aged ≥18 years old
• Requiring mechanical ventilation
• Commencing ventilation within the previous 24 hours
• Expected to be ventilated for minimum of ≥72 hours

You may not qualify if:

• Known prior diagnosis of cognitive impairment
• Known prior mental ill health
• Known malignancy
• Admitted after presenting with any of the following conditions:
• trauma
• brain injury
• surgery
• cardiac arrest
• immunosuppressed
• underlying pyogenic infection
• Not expected to survive to completion of the study

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rebecca Cusack

CONTACT

023 8120 5308; rebecca.cusack@uhs.nhs.uk

Study Design

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

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: February 14, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

GB (1)