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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02304224
• Other study ID #: 040114002
• Status: Not yet recruiting
• Phase: N/A
• First received: November 24, 2014
• Last updated: November 25, 2014
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: November 2014
• Source: Shanghai 10th People's Hospital
• Contact: Yuanzhuo Chen, M.D.
• Phone: +821666304586
• Email: chenyuanzhuo021[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Description:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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).

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Immune Suppression
• Sepsis
• Sleep Deprivation
• Toxemia

Intervention

Other:
• eye masks
eye masks from 21:00 to 6:00 each night during admission

Locations

Country	Name	City	State
China	Shanghai Tenth Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

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