Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis

NCT ID: NCT05052203

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-12-31

Brief Summary

Sepsis is a life-threatening dysregulated immune response to infection associated with multi-organ failure and a high mortality rate.While researchers have focused mainly on acute sepsis, post-sepsis care of survivors has long been neglected despite the observation that many sepsis survivors suffer from debilitating post-sepsis syndrome. This syndrome is characterized by frequent hospital readmissions and increased mortality due to persistent immune dysfunction, cardiovascular disease, and cognitive impairment, causing poor quality of life and a substantial burden on the healthcare system. Disconcertingly, the number of sepsis survivors at risk for hospital readmission continues to rise.7 Of the post-sepsis symptoms, post-sepsis immunosuppression is perhaps the most clinically important. While sepsis presents as an initial phase of hyperinflammation (a "cytokine storm"), it is followed by an immunosuppressive phase that is now understood to last weeks to months and predisposes survivors to lethal secondary infections and sepsis recurrence. A third of deaths eight years post-sepsis are caused by recurrent sepsis.We hypothesize that changes in the transcriptome and DNA methylome in immune cells of survivors might be the underlying driver for prolonged immunosuppression, and may also be correlated with long-term morbidity and mortality post-sepsis, as well as other symptoms of post-sepsis syndrome including PTSD and cardiovascular disease.

Conditions

Sepsis; Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Exposure of interest: study DNA methylation (epigenetics) and gene expression (transcriptomics) of blood leukocytes

The primary objective is to study DNA methylation (epigenetics) and gene expression (transcriptomics) of blood leukocytes between sepsis survivors at ED admission and three months after hospital discharge

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 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
• 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)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hjalmar Bouma

OTHER

Sponsor Role: lead

Responsible Party

Hjalmar Bouma

Internist and Research Fellow

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Other Identifiers

202100108

Identifier Type: -

Identifier Source: org_study_id