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the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit

Primary Purpose

Sepsis, Sleep Deprivation, Immune Suppression

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
eye masks
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis focused on measuring sepsis, melatonin, Human Leukocyte Antigen-DR, outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Tenth Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Eye masks

Arm Description

the patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night

the patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission

Outcomes

Primary Outcome Measures

survival of participants

Secondary Outcome Measures

Cerebral Performance Category(CPC) of Participants
Cerebral Performance Category(CPC) of Participants
Glasgow Coma Scale (GCS) of Participants
Glasgow Coma Scale (GCS) of Participants

Full Information

First Posted
November 24, 2014
Last Updated
November 25, 2014
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02304224
Brief Title
the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
Official Title
the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Treatment for patients There are no significant difference in standardized treatment received by patients enrolled, as well as the light equipment bedside and the food supply time. Patients are randomly divided into Eye Masks Group and Control Group by computer tools. Patients in Eye Masks Group are applied with eye masks from 22: 00 to 6: 00 each night during the admission. Blood sample was collected from each patient immediately after enrollment (D0), 6:30 of Day 1 (D1), Day 1 (D2), Day 3 (D3), Day 4 (D4) after admission. Urine of 6:00-21:00 and 21:00-6:00 is also stored from D0 to D4. Clinical data collection Data such as patient's age, gender, contact information, time from onset to admission, existence of septic shock, pathogen species, the site of infection, the existence of organ dysfunction, APACHE II score (Acute Physiology And Chronic Health Evaluation Scoring System) , SOFA (Sequential Organ Failure Assessment)score, the use of mechanical ventilation, vasoactive drugs, corticosteroids, sedative and analgesic medication, history of eye diseases and neurological diseases is collected from each patient who is included in the study. Follow-up data for daily daytime sleep time, existence of delirium, CPC score and GCS score on Day 7 and Day 28, length of stay and survival of 28 days after admission is also collected. Sample collection and processing The blood samples collected in citrate anticoagulation tubes and the urine samples collected in specialized graduated cylinders are stored at room temperature. Staining and fixation were performed within 24 h after blood collection. The expression of Monocyte Human Leukocyte Antigen-DR is detected using flow cytometer. The concentration of 6-sulfatoxymelatonin in urine is detected by ELISA kit. Cerebral Performance Category (CPC) CPC is a 5-category scale for measuring neurological status 2 weeks after cardiac arrest and CPC score 6 months after cardiac arrest. The 5 categories are: CPC 1, conscious and alert with good cerebral performance; CPC 2, conscious and alert with moderate cerebral performance; CPC 3, conscious with severe cerebral disability; CPC 4, comatose or in persistent vegetative state; and CPC 5, brain dead, circulation preserved. Glasgow Coma Scale (GCS) The GCS was developed as a standardized method for healthcare practitioners to evaluate degree of altered consciousness in patients who had sustained head injuries. The GCS is comprised of three categories: eye opening, verbal response, and motor response. The score from each category is summed, to provide a total GCS score (range 3-15).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Sleep Deprivation, Immune Suppression
Keywords
sepsis, melatonin, Human Leukocyte Antigen-DR, outcome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
the patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night
Arm Title
Eye masks
Arm Type
Experimental
Arm Description
the patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission
Intervention Type
Other
Intervention Name(s)
eye masks
Intervention Description
eye masks from 21:00 to 6:00 each night during admission
Primary Outcome Measure Information:
Title
survival of participants
Time Frame
up to 28 days after hospitalization
Secondary Outcome Measure Information:
Title
Cerebral Performance Category(CPC) of Participants
Time Frame
up to 7 days after hospitalization
Title
Cerebral Performance Category(CPC) of Participants
Time Frame
up to 28 days after hospitalization
Title
Glasgow Coma Scale (GCS) of Participants
Time Frame
up to 7 days after hospitalization
Title
Glasgow Coma Scale (GCS) of Participants
Time Frame
up to 28 days after hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanzhuo Chen, M.D.
Phone
+821666304586
Email
chenyuanzhuo021@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjie Li, M.D.
Email
kingnever@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuanzhuo Chen, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wenjie Li, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huiqi Wang, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chengjin Gao, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hu Peng, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yugang Zhuang, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiangyu Zhang, M.D.
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Tenth Hospital
City
Shanghai
ZIP/Postal Code
200000
Country
China

12. IPD Sharing Statement

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