Sepsis Clinical Trial
Official title:
the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
The aim of the study is to investigate the relationship of nocturnal use of eye masks and immune function, cerebral function and outcomes of patients with sepsis. Thus more efficient and comprehensive treatment could be provided for patients in the duration of admission in intensive care unit.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | February 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Transferred into ICU before 21:00 the same day; 2. Consistent with the diagnosis of sepsis; 3. Written informed consent was obtained from patients or their family members. Exclusion Criteria: 1. Age < 18 years; 2. With sleep disorders; mental illness; cancer; autoimmune diseases; dysfunction of liver or kidney; 3. History of using of immune-related drugs; melatonin receptor agonist or antagonist; sleep-aid or mental- related drugs; 4. History of accepting radiotherapy or chemotherapy; 5. Doing shift work before admission. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
China | Shanghai Tenth Hospital | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Shanghai 10th People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | survival of participants | up to 28 days after hospitalization | Yes | |
Secondary | Cerebral Performance Category(CPC) of Participants | up to 7 days after hospitalization | Yes | |
Secondary | Cerebral Performance Category(CPC) of Participants | up to 28 days after hospitalization | Yes | |
Secondary | Glasgow Coma Scale (GCS) of Participants | up to 7 days after hospitalization | Yes | |
Secondary | Glasgow Coma Scale (GCS) of Participants | up to 28 days after hospitalization | Yes |
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