Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

NCT05679661 · tracked via the Priya Life Science China tracker

Sponsor

Huang YuGuang

Phase

Not applicable

Started

2023-02-06

Last updated

2025-03-03

Condition(s) studied

Postoperative Complications

Investigational drug(s) / intervention(s)

immunonutritionoral chlorhexidine decontamination

immunonutrition: Patients in the intervention group will receive additional immunonutrition supplementation, which is oral intake of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery.

oral chlorhexidine decontamination: Patients in the intervention group will receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.

Study summary

Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. This study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

Eligibility

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. age≥65 years; 2. undergoing non-cardiac surgery (expected duration \>2 hours); 3. scheduled for general anesthesia and endotracheal intubation; 4. ASA classification I-IV; 5. with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia); 6. inform consent obtained Exclusion Criteria: 1. emergency surgery; 2. preoperative pneumonia; 3. allergic to chlorhexidine; 4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation; 5. expected intervention of immunonutrition\<3 days.

Primary outcome measure(s)

postoperative pulmonary complications — within 7 days after surgery
evaluated by trained investigator

Trial sites (1)

Facility	City	Region	Status
Peking Union Medical College Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05679661 on ClinicalTrials.gov ↗ ← All trials in China