Incidence and Risk Factors of PostopeRativE Delirium in ICU in China

NCT03704324 | Unknown

• 1 other identifier: 2018ZSLC08
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative delirium (POD) is a common postoperative complication that can occur in patients of any age. POD brings great burden to patients and their families, as the following cognitive decline may persist for months to years to impede patients returning to previous life quality and employment. The PREDICt study aims to characterize the incidence and profiles of POD in ICU, and to find out risk factors, especially any are modifiable, and any have value for developing prediction model. Our final aim is to comprehensively and deeply explore the etiology of POD to guide prevention of delirium among postoperative patients.

Conditions

Postoperative Delirium; Intensive Care Psychiatric Disorder

Keywords

Incidence and profile; Risk factors; Prediction model

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative delirium

  Investigators screen delirium by CAM-ICU twice a day, each time during day and night. Investigators defined patients have delirium if they had at least one positive screening during ICU stay.

  up to 20 days postoperatively

Secondary Outcomes (2)

• Severity of postoperative delirium

  up to 20 days postoperatively

• duration of postoperative delirium

  up to 20 days postoperatively

Eligibility Criteria

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

Study Population

Patients aged above 18 who are admitted to surgical SICUs after operation will be screened for eligibility.

You may qualify if:

• Aged above 18
• Surgical patients
• Admitted to ICU after surgery

You may not qualify if:

• Preoperative delirium or dementia patients
• Unable to fully participate in delirium testing, including blind, deaf, illiterate or inability to understand Chinese
• Undergoing surgery procedures do not require admission to SICU
• Transfer to SICU from wards after surgery

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 20032, China

RECRUITING

Related Publications (2)

• Cai S, Cui H, Pan W, Li J, Lin X, Zhang Y. Two-stage prediction model for postoperative delirium in patients in the intensive care unit after cardiac surgery. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezac573. doi: 10.1093/ejcts/ezac573.

  PMID: 36579859 DERIVED

• Wang H, Zhao QY, Luo JC, Liu K, Yu SJ, Ma JF, Luo MH, Hao GW, Su Y, Zhang YJ, Tu GW, Luo Z. Early prediction of noninvasive ventilation failure after extubation: development and validation of a machine-learning model. BMC Pulm Med. 2022 Aug 8;22(1):304. doi: 10.1186/s12890-022-02096-7.

  PMID: 35941641 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yuxia Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shining Cai

CONTACT

+86 18818260719; cai.shining@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: September 1, 2018
• First Posted: October 12, 2018
• Study Start: November 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Estimated from 2019
• Access Criteria: Study protocol has been published in Journal of advanced nursing

Locations

CN (1)