Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Not Applicable

Recruiting

• Conditions: Postoperative Complications
• Interventions: Behavioral: oral chlorhexidine decontamination; Dietary Supplement: immunonutrition

• Registration Number: NCT05679661
• Lead Sponsor: Huang YuGuang

Brief 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.

Detailed Description

This study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2022-12-26
• Study First Posted: 2023-01-11
• Study Start: 2023-02-06
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03
• Primary Completion: 2025-12-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 590

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)	oral chlorhexidine decontamination	Patients will be advised to follow a standard nutrition advice with a total intake of 30kcal/kg/d and protein intake of 1.2g/kg/d. Patients will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)	immunonutrition	Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)	oral chlorhexidine decontamination	Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.
Group B (immunonutrition and routine oral care, IN&RC)	immunonutrition	Patients will receive immunonutrition supplement of ORAL IMPACT™ 2 servings per day from the day of allocation at the preoperative anesthesia clinic until the day before surgery and routine oral care.

Primary Outcome Measures

Name	Time	Method
postoperative pulmonary complications	within 7 days after surgery	evaluated by trained investigator

Secondary Outcome Measures

Name	Time	Method
postoperative pneumonia	within 7 days after surgery	defined according to the US Centers for Disease Control Definition
postoperative recovery	within 30 days after surgery	evaluated by QoR-15 and WHODAS2.0
Comprehensive complication index (CCI)	within 30 days after surgery	postoperative complication evaluated using Comprehensive complication index
Length of hospital stay	From date of surgery until discharge day, assessed up to 4 weeks	Postoperative length of hospital stay assessed by days

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Peking, China