Circadian Rhythm and Delirium in ICU

NCT05342987 | Completed

• 1 other identifier: 2021ZSYQ17
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Rhythm; Sleep Quality; Intensive Care Unit Delirium

Outcome Measures

Primary Outcomes (3)

• Changes of melatonin level

  Test Serum melatonin level

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

• Sleep Quality

  Investigators screen sleep quality by Richards-Campbell Sleep Questionnaire

  up to 14 days after admission in ICU

• Changes of cortisol level

  Test Serum cortisol level

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

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged above 18 who are admitted to ICU will be screened for eligibility.

You may qualify if:

• Aged above 18
• RASS\>-4

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

• Li J, Cai S, Liu X, Mei J, Pan W, Zhong M, Zhang Y. Circadian rhythm disturbance and delirium in ICU patients: a prospective cohort study. BMC Anesthesiol. 2023 Jun 13;23(1):203. doi: 10.1186/s12871-023-02163-4.

  PMID: 37312021 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample will be taken to measure melatonin level using ELISA kit (produced by abcam)

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 25, 2022
• Study Start: February 15, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 31, 2023
• Last Updated: May 11, 2025

Record last verified: 2022-03

Locations

CN (1)