Postoperative ComplicationsNCT05679661
Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients
A study testing immunonutrition and oral chlorhexidine decontamination in people with Postoperative Complications, run by Huang YuGuang at 1 site in China.
Trial summary
Elderly patients are vulnerable to postoperative complications. Preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- immunonutrition and oral chlorhexidine decontamination
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2023to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Lu Che, M.D, tracymaobao@126.com
About this study
Official title: Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Postoperative Complications
- Being tested
- immunonutrition, oral chlorhexidine decontamination
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunonutritionDietary 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 decontaminationBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pulmonary complications
evaluated by trained investigator
Measured: within 7 days after surgery
Secondary outcomes (4)
postoperative pneumonia
defined according to the US Centers for Disease Control Definition
Measured: within 7 days after surgery
postoperative recovery
evaluated by QoR-15 and WHODAS2.0
Measured: within 30 days after surgery
Comprehensive complication index (CCI)
postoperative complication evaluated using Comprehensive complication index
Measured: within 30 days after surgery
Length of hospital stay
Postoperative length of hospital stay assessed by days
Measured: From date of surgery until discharge day, assessed up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start6 Feb 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huang YuGuang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huang YuGuang, Peking Union Medical College Hospital
- Investigators
- Yuguang Huang, Principal investigator, Peking Union Medical College Hospital (CAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679661
- Sponsor's protocol ID
- K2870
- Status last verified
- Feb 2025
- First submitted
- 26 Dec 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05679661
- Acronym / sponsor ID
- K2870
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Huang YuGuangUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD) | Experimental | Dietary Supplement: immunonutrition, Behavioral: oral chlorhexidine decontaminationPatients 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) | Experimental | Dietary Supplement: immunonutritionPatients 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. |
| Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) | Experimental | Behavioral: oral chlorhexidine decontaminationPatients 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 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunonutritionPatients 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. | Dietary supplement | Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD), Group B (immunonutrition and routine oral care, IN&RC) |
| oral chlorhexidine decontaminationPatients 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. | Behavioural | Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD), Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD) |
Primary outcome
postoperative pulmonary complications
Time frame: within 7 days after surgery
evaluated by trained investigator
4 secondary outcomes
postoperative pneumonia
Time frame: within 7 days after surgery
postoperative recovery
Time frame: within 30 days after surgery
Comprehensive complication index (CCI)
Time frame: within 30 days after surgery
Length of hospital stay
Time frame: From date of surgery until discharge day, assessed up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yuguang Huang principal investigator
Peking Union Medical College Hospital (CAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immunonutrition and oral chlorhexidine decontamination in people with Postoperative Complications, run by Huang YuGuang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Che, MD (69152020, tracymaobao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pulmonary complications (time frame: within 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.