Perioperative Database of Chinese Elderly Patients (PDCEP)

The investigators aim to establish a prospective database of perioperative elderly patients from multiple regions and centers. Collected data involves postoperative complications of the central nervous system, cardiovascular system, kidney, respiratory system, infection, pain, and other perioperative complications. Based on the database, the investigators intend to explore:

• The incidence and risk factors of perioperative morbidity and mortality in elderly patients;
• Perioperative risk assessment methods and early warning models for elderly patients;
• Practical, safe, and effective risk prevention and control system through subsequent studies.

Study Overview

• Status: Recruiting
• Conditions: Perioperative/Postoperative Complications; Perioperative Adverse Events; Perioperative Complications
• Intervention / Treatment: Other: no intervention

Detailed Description

As the population aging is speeding up, senile diseases have become a significant and severe public health problem, influencing national health. More than 20 million elderly patients undergo surgery each year in China, accounting for a quarter of the population who undergo surgery. Advanced age and comorbid diseases render the elderly at increased risk of postoperative morbidity and mortality. The incidence of postoperative complications is twice that of non-elderly patients, and mortality rates are five times higher than non-elderly patients. Thus, it is a significant challenge to safely and stably ensure the elderly are in an optimal perioperative period.

For the good of optimizing perioperative management, it is urgent to build a large-sample, multi-center database. Based on this database, the investigators can explore new risk assessment methods and establish a perioperative risk prediction model and early warning system suitable for elderly patients. It will help improve this group of patients' short- and long-term outcomes and thus reduce the economic burden of national health and medical resources.

In this context, establishing a clinical database including data for all perioperative elderly patients is of high interest. This database will allow the investigators to carry out clinical research on:

• Clinical, biological, and genetic factors predictive of perioperative complications and deaths;
• Systematic and individualized evaluation tools for elderly patients;
• Prognostic factors for improving short- and long-term outcomes. This is particularly significant for rare clinical evidence of perioperative elderly patients for which the current knowledge is scarce.

The database will also allow the investigators to develop or participate in multi-center trials, national or international, and facilitate the formation of perioperative data collection standards.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Weidong Mi, PhD; Phone Number: 8613381082966; Email: wwdd1962@aliyun.com
• Study Contact Backup: Name: Jingsheng Lou, PhD; Phone Number: 8613811065322; Email: loujingsheng@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Weidong Mi, PhD; Phone Number: 8613381082966; Email: wwdd1962@aliyun.com
      • Contact: Jingsheng Lou, PhD; Phone Number: 8613811065322; Email: loujingsheng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Hospital-based, elderly patients, perioperative/postoperative outcome/complications study

Description

Inclusion Criteria:

• Geriatric surgical patients ≥65 years old, undergoing elective surgery with a planned overnight hospital stay following surgery.

Exclusion Criteria:

• Patients fully refused to participate in the study;
• Patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status were excluded;
• Patients whose surgeries were canceled;
• Patients accepted cardiac surgeries were excluded from the heart injury section;
• Patients accepted cardiac, neurosurgeries or were excluded from postoperative central nervous system and pain observation section;
• Patients refused to participate in neurocognitive, anxiety, depression, or pain questionnaire were excluded from relative assessment and measurement.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
elderly patients (aged ≥ 65 years); elderly patients undergo surgeries	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Clinical data of postoperative complications in the medical record and follow-up update. Postoperative complications, including central nervous system injury, heart injury, acute kidney injury, lung injury, infection, and pain.	Up to 30 days
Postoperative Survival	Clinical data of survival in the medical record and follow-up update.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of survival rate	collection of clinical data in the medical record and follow-up update	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Survival	Clinical data of survival in the medical record and follow-up update.	1 year after surgeries
Postoperative complications	Clinical data of postoperative complications in the medical record and follow-up update. Postoperative complications, including central nervous system injury, heart injury, acute kidney injury, lung injury, infection, and pain.	1 year after surgeries

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Peking University First Hospital; Xiangya Hospital of Central South University; Peking University People's Hospital; Sun Yat-sen University; Fudan University; Beijing Tiantan Hospital; Shanghai Zhongshan Hospital; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Beijing Anzhen Hospital; China-Japan Friendship Hospital; Wuhan Union Hospital, China; Central South University; Zhejiang University; The Affiliated Hospital Of Guizhou Medical University; Zhejiang Provincial People's Hospital; First Affiliated Hospital of Xinjiang Medical University; Taihe Hospital; First Affiliated Hospital of Guangxi Medical University
• Investigators: Study Chair: WEIDONG MI, PhD, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): April 30, 2022
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2023
• Last Update Submitted That Met QC Criteria: May 30, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: pain; acute kidney injury; infection; lung injury; central nervous system complications; heart injury
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: PLAGH-AOC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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