the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable sepsis
Started Dec 2014
1 active site
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
November 24, 2014
CompletedFirst Posted
Study publicly available on registry
December 1, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedDecember 1, 2014
November 1, 2014
1 year
November 24, 2014
November 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
survival of participants
up to 28 days after hospitalization
Secondary Outcomes (4)
Cerebral Performance Category（CPC) of Participants
up to 7 days after hospitalization
Cerebral Performance Category（CPC) of Participants
up to 28 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
up to 7 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
up to 28 days after hospitalization
Study Arms (2)
Control
NO INTERVENTIONthe patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night
Eye masks
EXPERIMENTALthe patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission
Interventions
Eligibility Criteria
You may qualify if:
- Transferred into ICU before 21:00 the same day;
- Consistent with the diagnosis of sepsis;
- Written informed consent was obtained from patients or their family members.
You may not qualify if:
- Age \< 18 years;
- With sleep disorders; mental illness; cancer; autoimmune diseases; dysfunction of liver or kidney;
- History of using of immune-related drugs; melatonin receptor agonist or antagonist; sleep-aid or mental- related drugs;
- History of accepting radiotherapy or chemotherapy;
- Doing shift work before admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Tenth Hospital
Shanghai, 200000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yuanzhuo Chen, M.D.
Shanghai 10th People's Hospital
- PRINCIPAL INVESTIGATOR
Wenjie Li, M.D.
Shanghai 10th People's Hospital
- PRINCIPAL INVESTIGATOR
Huiqi Wang, M.D.
Shanghai 10th People's Hospital
- STUDY DIRECTOR
Chengjin Gao, M.D.
Shanghai 10th People's Hospital
- STUDY DIRECTOR
Hu Peng, M.D.
Shanghai 10th People's Hospital
- PRINCIPAL INVESTIGATOR
Yugang Zhuang, M.D.
Shanghai 10th People's Hospital
- STUDY DIRECTOR
Xiangyu Zhang, M.D.
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 24, 2014
First Posted
December 1, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
December 1, 2014
Record last verified: 2014-11