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NCT Number: NCT05679661

Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, China

Location status: Recruiting

Location contact

Lu Che, M.D

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. postoperative pulmonary complications

    Time frame: within 7 days after surgery

    evaluated by trained investigator

Secondary outcomes

  1. postoperative pneumonia

    Time frame: within 7 days after surgery

    defined according to the US Centers for Disease Control Definition

  2. postoperative recovery

    Time frame: within 30 days after surgery

    evaluated by QoR-15 and WHODAS2.0

  3. Comprehensive complication index (CCI)

    Time frame: within 30 days after surgery

    postoperative complication evaluated using Comprehensive complication index

  4. Length of hospital stay

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

    Postoperative length of hospital stay assessed by days

Study contacts

Contact information is provided by the study sponsor or research team.

Jiawen Yu, MD

CONTACT

[email protected]

69152020

Lu Che, MD

CONTACT

[email protected]

69152020

Sponsors and collaborators

Lead sponsor

Huang YuGuang

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 11, 2023
Registry last updated
Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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