Researching the Effects of Sepsis on Quality Of life, Vitality, Epigenome and gene expression during RecoverY from sepsis (REQOVERY)

Researching the Effects of Sepsis on Quality Of life, Vitality, Epigenome and gene expression during RecoverY from sepsis (REQOVERY) - REQOVERY

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50782

Enrollment

120

Registered

2021-06-23

Start date

2021-10-08

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis sepsis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria sepsis group: - Adult patients, aged between 18 and 85 years - Able to provide informed consent themselves or informed consent can be obtained via next of kin or legal guardian - Included in Acutelines, where blood sample were was drawn within 24 hours upon of ED admission according to Acutelines protocol - Satisfy the Sepsis-3 criteria for sepsis (Figure 2), combined with clinical suspicion of infection and/or fever (body temperature > 38.5°C) - Survive at 3 months post discharge Inclusion criteria control group: adult patients, aged between 18 and 85 years - Able to provide informed consent themselves or informed consent can be obtained via next of kin or legal guardian - Included in Acutelines, where blood sample was drawn upon ED admission - Non-infectious reason of admission, specifically syncope, electrolyte disturbance, intoxication, gastro-intestinal bleeding, undifferentiated complaints

Exclusion criteria

Exclusion criteria: - Transfer from another hospital - Emergency room visit in connection with accidental exposure of bodily material to patient ("needle stick injury") - Visit an emergency room in connection with organ transplantation - Discharged home without hospital admittance after ED visit - Unable to give blood - Immunosuppressive therapies such as corticosteroids (>10mg) or small molecule immune suppressants within the last three months, or biologicals administered within the last year - Radiotherapy or systemic chemotherapy within the last three months - Known pregnancy; the presence of pregnancy will be verified by asking the potential participant - A hospitalization of more than 21 days

Design outcomes

Primary

Measure	Time frame
The primary objective of the current project is to measure changes in DNA methylation (i.e. epigenetics) and gene expression (i.e. transcriptomics) of blood leukocytes between sepsis survivors at ED admission and three months after hospital discharge.	—

Secondary

Measure	Time frame
The secondary objectives are to correlate these changes with DNA methylation and gene expression with clinical data of sepsis survivors including post-sepsis syndrome symptoms (e.g. cognition, neuropsychiatric symptoms, quality of life), cytometric and biochemical parameters that assess organ function, rehospitalization frequency, and mortality, as well as the soluble proteome and metabolome in blood to explore regulatory mechanisms. Lastly, we will compare the DNA methylation and gene expression profile with the age and sex-matched control group.	—

Measure

Time frame

The secondary objectives are to correlate these changes with DNA methylation and gene expression with clinical data of sepsis survivors including post-sepsis syndrome symptoms (e.g. cognition, neuropsychiatric symptoms, quality of life), cytometric and biochemical parameters that assess organ function, rehospitalization frequency, and mortality, as well as the soluble proteome and metabolome in blood to explore regulatory mechanisms. Lastly, we will compare the DNA methylation and gene expression profile with the age and sex-matched control group.

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Countries

Netherlands

Outcome results