SepsisNCT02304224
the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
A study testing eye masks in people with Sepsis and Sleep Deprivation, run by Shanghai 10th People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Sleep Deprivation, Immune Suppression
- What is being tested?
- eye masks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Wenjie Li, M.D. contact
About this study
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.
Read the 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).
- Conditions
- Sepsis, Sleep Deprivation, Immune Suppression
- Being tested
- eye masks
- Keywords
- sepsis, melatonin, Human Leukocyte Antigen-DR, outcome
- Medical subject headings
- Sepsis, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye masksOther
eye masks from 21:00 to 6:00 each night during admission
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | the patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night |
| Eye masks | Experimental | the patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission Receives: Other: eye masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival of participants
Measured: up to 28 days after hospitalization
Secondary outcomes (4)
Cerebral Performance Category（CPC) of Participants
Measured: up to 7 days after hospitalization
Cerebral Performance Category（CPC) of Participants
Measured: up to 28 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
Measured: up to 7 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
Measured: up to 28 days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Yuanzhuo, Shanghai 10th People's Hospital
- Investigators
- Yuanzhuo Chen, M.D., Study chair, Shanghai 10th People's HospitalWenjie Li, M.D., Principal investigator, Shanghai 10th People's HospitalHuiqi Wang, M.D., Principal investigator, Shanghai 10th People's HospitalChengjin Gao, M.D., Study director, Shanghai 10th People's HospitalHu Peng, M.D., Study director, Shanghai 10th People's HospitalYugang Zhuang, M.D., Principal investigator, Shanghai 10th People's HospitalXiangyu Zhang, M.D., Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304224
- Sponsor's protocol ID
- 040114002
- Status last verified
- Nov 2014
- First submitted
- 24 Nov 2014
- Last updated
- 1 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Relationship of the Use of Eye Masks and Outcomes of Patients With Sepsis in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02304224
- Acronym / sponsor ID
- 040114002
- Conditions
- Sepsis, Sleep Deprivation, Immune Suppression
- Keywords
- sepsis, melatonin, Human Leukocyte Antigen-DR, outcome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 1 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –the patients with sepsis admitted in the intensive care unit aren't applied with eye masks at night |
| Eye masks | Experimental | Other: eye masksthe patients with sepsis in the intensive care unit are applied with eye masks at night in the duration of admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eye maskseye masks from 21:00 to 6:00 each night during admission | Other | Eye masks |
Primary outcome
survival of participants
Time frame: up to 28 days after hospitalization
4 secondary outcomes
Cerebral Performance Category（CPC) of Participants
Time frame: up to 7 days after hospitalization
Cerebral Performance Category（CPC) of Participants
Time frame: up to 28 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
Time frame: up to 7 days after hospitalization
Glasgow Coma Scale (GCS) of Participants
Time frame: up to 28 days after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenjie Li, M.D. contact
Yuanzhuo Chen, M.D. study chair
Shanghai 10th People's Hospital
Wenjie Li, M.D. principal investigator
Shanghai 10th People's Hospital
Huiqi Wang, M.D. principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye masks in people with Sepsis and Sleep Deprivation, run by Shanghai 10th People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanzhuo Chen, M.D. (+821666304586, chenyuanzhuo021@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
survival of participants (time frame: up to 28 days after hospitalization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2014.