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Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

Primary Purpose

Postoperative Complications

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immunonutrition
oral chlorhexidine decontamination
Sponsored by
Huang YuGuang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

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

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

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

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

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

postoperative complications
evaluated by comprehensive complication index (CCI)

Secondary Outcome Measures

postoperative pneumonia
defined according to the US Centers for Disease Control Definition
postoperative recovery
evaluated by QoR-15

Full Information

First Posted
December 26, 2022
Last Updated
February 11, 2023
Sponsor
Huang YuGuang
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1. Study Identification

Unique Protocol Identification Number
NCT05679661
Brief Title
Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients
Official Title
Effect of Perioperative Immunonutrition Intervention and Oral Decontamination on Postoperative Complications in Elderly: a Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huang YuGuang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (immunonutrition and oral chlorhexidine decontamination, IN&CD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B (immunonutrition and routine oral care, IN&RC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group C (routine nutrition advice and oral chlorhexidine decontamination, RN&CD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group D (routine nutrition advice and routine oral care, RN&RC)
Arm Type
No Intervention
Arm Description
Patients will be advised to follow a standard nutrition advice and routine oral care.
Intervention Type
Dietary Supplement
Intervention Name(s)
immunonutrition
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
oral chlorhexidine decontamination
Intervention Description
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 Outcome Measure Information:
Title
postoperative complications
Description
evaluated by comprehensive complication index (CCI)
Time Frame
within 7 days after surgery
Secondary Outcome Measure Information:
Title
postoperative pneumonia
Description
defined according to the US Centers for Disease Control Definition
Time Frame
within 7 days after surgery
Title
postoperative recovery
Description
evaluated by QoR-15
Time Frame
within 30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Che, MD
Phone
69152020
Email
tracymaobao@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiawen Yu, MD
Phone
69152020
Email
jiawen_yu@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuguang Huang
Organizational Affiliation
Peking Union Medical College Hospital (CAMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Peking
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Che, M.D
Email
tracymaobao@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Perioperative Immunonutrition Intervention and Oral Decontamination in Elderly Surgical Patients

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