Postoperative DeliriumPREDICtNCT03704324
Incidence and Risk Factors of PostopeRativE Delirium in ICU in China
An observational study of Postoperative Delirium and Intensive Care Psychiatric Disorder, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Intensive Care Psychiatric Disorder
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2018to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged above 18 who are admitted to surgical SICUs after operation will be screened for eligibility.
Who may be able to join
- Aged above 18
- Surgical patients
- Admitted to ICU after surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, 20032
Shining Cai, MSc, 86-021-64041990 ext. 2724, cai.shining@zs-hospital.sh.cn
Yuxia Zhang, PhD
About this study
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.
Read the 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.
- Keywords
- Incidence and profile, Risk factors, Prediction model
- Medical subject headings
- Emergence Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 20 days postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: up to 20 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Nov 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuxia Zhang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704324
- Sponsor's protocol ID
- 2018ZSLC08
- Acronym
- PREDICt
- Status last verified
- Dec 2021
- First submitted
- 1 Sep 2018
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol has been published in Journal of advanced nursing
Publications
Zhu A, Liu Y, Guan T, Ju M, Du Y, Latour JM, Hong Y, Lin X, Cai S, Zhang Y. Data-driven subtypes of postoperative delirium in surgical ICU patients: a secondary analysis of a prospective cohort study. Anaesth Crit Care Pain Med. 2026 Jul 13:101894. doi: 10.1016/j.accpm.2026.101894. Online ahead of print.
PubMed 42442477Cai 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.
PubMed 36579859Wang 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.
PubMed 35941641
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of PostopeRativE Delirium in ICU in China
- ClinicalTrials.gov ID
- NCT03704324
- Acronym / sponsor ID
- PREDICt / 2018ZSLC08
- Keywords
- Incidence and profile, Risk factors, Prediction model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 12 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged above 18 who are admitted to surgical SICUs after operation will be screened for eligibility.
Key inclusion criteria (3 listed)
- Aged above 18
- Surgical patients
- Admitted to ICU after surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium
Time frame: up to 20 days postoperatively
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.
2 secondary outcomes
Severity of postoperative delirium
Time frame: up to 20 days postoperatively
duration of postoperative delirium
Time frame: up to 20 days postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Derived from this study: PubMed 42442477Zhu A, Liu Y, Guan T, Ju M, Du Y, Latour JM, Hong Y, Lin X, Cai S, Zhang Y. Data-driven subtypes of postoperative delirium in surgical ICU patients: a secondary analysis of a prospective cohort study. Anaesth Crit Care Pain Med. 2026 Jul 13:101894. doi: 10.1016/j.accpm.2026.101894. Online ahead of print.
- Derived from this study: PubMed 36579859Cai 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.
- Derived from this study: PubMed 35941641Wang 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.
- Individual participant dataSharing planned: Yes. Study protocol has been published in Journal of advanced nursing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxia Zhang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium and Intensive Care Psychiatric Disorder, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shining Cai (+86 18818260719, cai.shining@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (time frame: up to 20 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03704324, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2022.