Status:
RECRUITING
Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly
Lead Sponsor:
Peking Union Medical College Hospital
Collaborating Sponsors:
Fujian Provincial Hospital
The Second Hospital of Hebei Medical University
Conditions:
Postoperative Complications
Pulmonary Complication
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complication...
Detailed Description
This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients a...
Eligibility Criteria
Inclusion
- age≥65 years;
- undergoing major non-cardiac surgery;
- scheduled for general anesthesia and endotracheal intubation;
- American Society of Anesthesiologists (ASA) physical status classification I-IV;
- with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
- informed consent obtained.
Exclusion
- emergency surgery;
- preoperative pneumonia;
- allergic to chlorhexidine;
- severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation;
- expected intervention of immunonutrition\<3 days.
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
592 Patients enrolled
Trial Details
Trial ID
NCT05971810
Start Date
August 23 2023
End Date
September 1 2025
Last Update
January 28 2025
Active Locations (2)
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1
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
2
Peking Union Medical College Hospital
Beijing, China