CharacterisatiON of carDiac funCTion in Intensive Care Unit Survivors of Sepsis.
CONDUCT-ICU
1 other identifier
observational
69
1 country
2
Brief Summary
Cardiac dysfunction is common following hospital admission with sepsis and one of the most frequent causes for readmissions to hospital, however underlying mechanisms by which this might occur are unclear. The CONDUCT-ICU investigators will conduct a pilot, cohort study, characterizing cardiac function in ICU survivors of sepsis using a combination of CMR imaging, biomarkers and patient reported outcome measures to investigate mechanisms of cardiac dysfunction following sepsis. Comparisons will be made to that of the general population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Mar 2023
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMarch 8, 2023
March 1, 2023
9 months
March 14, 2022
March 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Left Ventricular Ejection Fraction
LVEF is a validated marker of cardiovascular function. It can be used in diagnosis of heart failure and can assist in grading severity.
6-10 weeks post hospital discharge
Secondary Outcomes (16)
hs-Troponin (ng/L)
6-10 weeks post-hospital discharge
NT-proBNP (pg/ML)
6-10 weeks post-hospital discharge
CRP (mg/L)
6-10 weeks post discharge
IL-10 (pg/ml)
6-10 weeks post discharge
IL-1B (pg/ml)
6-10 weeks post discharge
- +11 more secondary outcomes
Study Arms (1)
ICU Survivors of Sepsis
ICU survivors of sepsis who would routinely attend ICU follow-up.
Interventions
Eligibility Criteria
ICU Survivors of Sepsis
You may qualify if:
- Provision of informed consent.
- Age \> 18 years.
- ICU admission with sepsis (According to The Third International Consensus Definitions for Sepsis and Septic Shock \[Sepsis-3\])17
- Ability to comply with study procedures
You may not qualify if:
- Inability to give informed consent
- Pregnancy.
- Ongoing participation in any investigational research that may undermine the scientific basis of the study.
- Contraindications to magnetic resonance imaging:
- i. Cardiac pacemaker, artificial heart valve, neurostimulator, cochlear implant ii. Aneurysm clips iii. Metal injuries to the eye iv. Loose metal in any part of the body v. Severe claustrophobia
- Known Coronary Artery Disease
- Previous Myocardial Infarction
- Chronic Heart Failure prior to ICU admission
- Patient receiving immune modulating drug or biologic therapy either long term or during acute admission
- Patient considered by the clinical team to be very unlikely to survive to hospital discharge
- Hospital Admission because of Covid-19
- Patients undergoing treatment for malignancy with systemic anti-cancer therapies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Greater Glasgow and Clydelead
- NHS Ayrshire and Arrancollaborator
- Golden Jubilee National Hospitalcollaborator
- University of Glasgowcollaborator
Study Sites (2)
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
University Hospital Crosshouse
Kilmarnock, KA2 0BE, United Kingdom
Related Publications (1)
Garrity K, Docherty C, Mangion K, Woodward R, Shaw M, Roditi G, Shelley B, Quasim T, McCall P, McPeake J. Characterizing Cardiac Function in ICU Survivors of Sepsis: A Pilot Study Protocol. CHEST Crit Care. 2024 Mar;2(1):100050. doi: 10.1016/j.chstcc.2024.100050.
PMID: 38524255DERIVED
Biospecimen
Serum samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
December 1, 2022
Study Start
March 1, 2023
Primary Completion
December 1, 2023
Study Completion
February 1, 2024
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share