Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Postoperative Complications Clinical Trial

Official title:

Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679661
• Other study ID #: K2870
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2023
• Source: Peking Union Medical College Hospital
• Contact: Lu Che, MD
• Phone: 69152020
• Email: tracymaobao[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Dietary Supplement:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking

Sponsors (1)

Lead Sponsor	Collaborator
Huang YuGuang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications	evaluated by comprehensive complication index (CCI)	within 7 days after surgery
Secondary	postoperative pneumonia	defined according to the US Centers for Disease Control Definition	within 7 days after surgery
Secondary	postoperative recovery	evaluated by QoR-15	within 30 days after surgery