Skip to main content
Clinical Trials/NCT05342987
NCT05342987
Completed
Not Applicable

The Relationship Between Delirium and Circadian Rhythm in Intensive Care Unit

Shanghai Zhongshan Hospital1 site in 1 country190 target enrollmentFebruary 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Circadian Rhythm
Sponsor
Shanghai Zhongshan Hospital
Enrollment
190
Locations
1
Primary Endpoint
Changes of melatonin level
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

The study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors. And explore the pathway of circadian rhythm on ICU delirium.

The hypothesis of study is that icu patients experience circadian and sleep rhythm disorder, especially in patient who have delirium.

Detailed Description

Delirium is an acute and fluctuating alteration of mental state characterized by a disturbance in attention, level of consciousness and cognition. At present, there is no unified conclusion on the pathogenesis of delirium. There are many different hypotheses, such as the neuroinflammation hypothesis, the neuronal aging hypothesis, the oxidative stress hypothesis, the neurotransmitter hypothesis, the neuroendocrine hypothesis and the circadian rhythm disturbance hypothesis. Among them, the circadian rhythm disturbance hypothesis believes that the circadian rhythm disorder caused by various reasons, which leads to sleep disturbance and melatonin secretion disorder promotes the occurrence of acute cognitive impairment, which in turn leads to the occurrence of delirium. Circadian rhythm refers to the rhythm of any biological process in the human body that repeats and maintains within 24 hours without external stimulation. By far, the most common way to measure circadian rhythm is through vital signs rhythms, hormone secretion (cortisol and melatonin levels), and sleep-wake cycle. Due to the special environment and treatment needs in ICU make patients' circadian rhythm easily broken, and produced a large latent harm to patients. Most studies are in the process of delirium and sleep research, selecting a small subgroup to evaluate the circadian rhythm indicators of patients, and the overall relationship between delirium and circadian rhythm is not clear. Thus, the study aims to investigate the status of circadian rhythm and sleep quality in ICU patients and their influence factors, and explore the pathway of circadian rhythm action on ICU delirium.

Registry
clinicaltrials.gov
Start Date
February 15, 2022
End Date
July 31, 2023
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai Zhongshan Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged above 18

Exclusion Criteria

  • History of mental or psychological illness
  • The patient remained in coma or deep sedation
  • Delirium was occurring at the time of admission
  • Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
  • Neurosurgery and maternal patients

Outcomes

Primary Outcomes

Changes of melatonin level

Time Frame: Three time a day in 3, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU

Test Serum melatonin level

Sleep Quality

Time Frame: up to 14 days after admission in ICU

Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire

Changes of cortisol level

Time Frame: Three time a day in 0, 8 and 16 clock on day 1 to day 3 and day 7 after admission in ICU

Test Serum cortisol level

Secondary Outcomes

  • ICU delirium(up to 14 days after admission in ICU)
  • patient outcome(up to 14 days after admission in ICU)
  • LOS(up to 14 days after admission in ICU)

Study Sites (1)

Loading locations...

Similar Trials