Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

NCT05679661 | Recruiting

• 1 other identifier: K2870
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• postoperative pulmonary complications

  evaluated by trained investigator

  within 7 days after surgery

Secondary Outcomes (4)

• postoperative pneumonia

  within 7 days after surgery

• postoperative recovery

  within 30 days after surgery

• Comprehensive complication index (CCI)

  within 30 days after surgery

• Length of hospital stay

  From date of surgery until discharge day, assessed up to 4 weeks

Study Arms (4)

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)

EXPERIMENTAL

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.

Dietary Supplement: immunonutrition; Behavioral: oral chlorhexidine decontamination

Group B (immunonutrition and routine oral care, IN&RC)

EXPERIMENTAL

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.

Dietary Supplement: immunonutrition

Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)

EXPERIMENTAL

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.

Behavioral: oral chlorhexidine decontamination

Group D (routine nutrition advice and routine oral care, RN&RC)

NO INTERVENTION

Patients will be advised to follow a standard nutrition advice and routine oral care.

Interventions

immunonutrition DIETARY_SUPPLEMENT

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.

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD); Group B (immunonutrition and routine oral care, IN&RC)

oral chlorhexidine decontamination BEHAVIORAL

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.

Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD); Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age≥65 years;
• undergoing non-cardiac surgery (expected duration \>2 hours);
• scheduled for general anesthesia and endotracheal intubation;
• ASA classification I-IV;
• with intermediate to high risk of respiratory complications assessed by ARISCAT score (Assess Respiratory Risk in Surgical Patients in Catalonia);
• inform consent obtained

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huang YuGuang: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Immunonutrition Diet

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Yuguang Huang

  Peking Union Medical College Hospital (CAMS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu Che, MD

CONTACT

69152020; tracymaobao@126.com

Jiawen Yu, MD

CONTACT

69152020; jiawen_yu@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 11, 2023
• Study Start: February 6, 2023
• Primary Completion: December 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)