Incidence and Risk Factors of PostopeRativE Delirium in ICU in China (PREDICt)

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Delirium; Intensive Care Psychiatric Disorder

Detailed Description

Delirium is an acute and fluctuating alteration of mental state characterized by a disturbance in attention, level of consciousness and cognition. Postoperative delirium (POD) is a common postoperative complication that can occur in patients of any age, from children to elderly. POD was proved to be associated with several worse outcome, including increased mechanically ventilated duration, hospital length of stay (LOS) and cost. Moreover, the each day with delirium is independently associated with an increased hazard of death by 10%. Although studies on delirium substantially increased in the past decade, many research gaps still exist in this area due to the heterogeneity of their results. First, the incidence varies broad range because the targeted population are different. In China, up to now, no large sample studies to investigate the incidence and risk factors of POD in ICU. Moreover, although there have been numerous studies exploring the potential risk factors of POD, most of them are still with inconclusive evidence. The Benzodiazepine use and blood transfusion administration are the only two modifiable factors with strong evidence. Hence, still needs further studies to focus on etiology of POD to find out modifiable and non-modifiable factors to verify the presumed factors. Since there is lack of effective treatments for POD, prevention remains the best strategy to cope with delirium. Predictive models that include delirium risk factors can guide us to early prevention of high risk patients. There were two high-quality studies on prediction models for ICU delirium, named PRE-DELIRIC model and E-PRE-DELIRIC model. However, both of the models are conducted in general ICU, did not fully consider the factors of surgery.

The PREDICt study aims to find out risk factors, especially any are modifiable, and any have value for developing prediction model. Our primary aim is to determine the incidence and severity of Post-Operative Delirium (POD) in ICU after surgery, and identify the associated outcomes and burdens of POD in ICU by evaluating the impact on postoperative outcome, ICU and hospital length of stay, medical expenses. Our secondary aim is to investigate the modifiable and non-modifiable risk factors for the occurrence of POD during ICU stay and develop delirium prediction model for ICU patients. Our final aim is to comprehensively and deeply explore the etiology of POD to guide prevention of delirium among postoperative patients.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Shining Cai; Phone Number: +86 18818260719; Email: cai.shining@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 20032
    • Recruiting
    • 180 Fenglin Road
    • Contact: Shining Cai, MSc; Phone Number: 2724 86-021-64041990; Email: cai.shining@zs-hospital.sh.cn
    • Principal Investigator: Yuxia Zhang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of postoperative delirium	Assess by CAM-ICU-7 if CAM-ICU is positive. Categorized as no delirium: 0-2, mild to moderate delirium: 3-5, and severe delirium: 6-7.	up to 20 days postoperatively
duration of postoperative delirium	Defined as time (in days) from the first positive CAM-ICU until the beginning of two consecutive days of negative CAM-ICU.	up to 20 days postoperatively

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Yuxia Zhang, Fudan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 1, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (ACTUAL): October 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Risk factors; Prediction model; Incidence and profile
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Problem Behavior; Mental Disorders
• Other Study ID Numbers: 2018ZSLC08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol has been published in Journal of advanced nursing
• IPD Sharing Time Frame: Estimated from 2019
• IPD Sharing Access Criteria: Study protocol has been published in Journal of advanced nursing
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No