Perioperative Database of Chinese Elderly Patients

NCT04911530 | Unknown

• 1 other identifier: PLAGH-AOC-001
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perioperative Complications; Perioperative/Postoperative Complications; Perioperative Adverse Events

Keywords

central nervous system complications; heart injury; acute kidney injury; lung injury; infection; pain

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (2)

• Postoperative Survival

  1 year after surgeries

• Postoperative complications

  1 year after surgeries

Study Arms (1)

elderly patients (aged ≥ 65 years)

elderly patients undergo surgeries

Other: no intervention

Interventions

no intervention OTHER

no intervention

elderly patients (aged ≥ 65 years)

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tiantan Hospital: collaborator
• Peking University First Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Xiangya Hospital of Central South University: collaborator
• Beijing Anzhen Hospital: collaborator
• Central South University: collaborator
• Peking University People's Hospital: collaborator
• Zhejiang University: collaborator
• Fudan University: collaborator
• Sun Yat-sen University: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• China-Japan Friendship Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Taihe Hospital: collaborator
• Zhejiang Provincial People's Hospital: collaborator
• Shanghai Zhongshan Hospital: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Heart Injuries; Acute Kidney Injury; Lung Injury; Infections; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thoracic Injuries; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Weidong Mi, PhD

  Chinese PLA General Hospital

  STUDY CHAIR

Central Study Contacts

Weidong Mi, PhD

CONTACT

8613381082966; wwdd1962@aliyun.com

Jingsheng Lou, PhD

CONTACT

8613811065322; loujingsheng@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Anesthesiology (Cheif expert of National key research and development program of China 2018YFC2001900)

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: June 3, 2021
• Study Start: April 1, 2020
• Primary Completion: April 30, 2022
• Study Completion: December 31, 2025
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

CN (1)