Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

592 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-23

Study Completion Date

2025-09-01

Brief Summary

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The goal of this multicenter randomized controlled trial is to explore the efficacy of perioperative oral decontamination and immunonutrition supplement to prevent postoperative pulmonary complications in elderly patients(≥65 years) receiving elective non-cardiac operations. Participants will be either given immunonutrition supplement versus routine nutrition advice, and oral chlorhexidine decontamination versus routine oral care randomly. The two interventions will be compared with control groups separately regarding postoperative pulmonary complications and other outcomes.

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Detailed Description

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This study is a prospective, multicenter, two-by-two factorial randomized controlled trial evaluating the efficacy of immunonutrition supplementation and oral chlorhexidine decontamination. Patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited. Participants will be excluded if they have contraindication to the intervention. The patients will be randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care, immunonutrition supplementation vs routine nutrition advice). The primary outcome is the incidence of postoperative pulmonary complications within 7 days after surgery. Secondary outcomes include incidence of pneumonia, infectious complications, comprehensive complication index, postoperative functional recovery, length of hospital stay and hospital expense.

Conditions

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Postoperative Complications Pulmonary Complication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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

Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. 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 Type EXPERIMENTAL

immunonutrition supplement of ORAL IMPACT™

Intervention Type DIETARY_SUPPLEMENT

For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.

oral chlorhexidine decontamination

Intervention Type OTHER

For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.

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

Patients in this group will receive immunonutrition supplementation from the day of allocation at the preoperative anesthesia clinic until the day before surgery (usually 1-3 weeks), which is oral intake of ORAL IMPACT™ 2 servings per day. For oral health care, they will receive routine oral care which is routine toothbrushing twice daily.

Group Type EXPERIMENTAL

immunonutrition supplement of ORAL IMPACT™

Intervention Type DIETARY_SUPPLEMENT

For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.

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

Patients in this group 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. They will also receive oral chlorhexidine decontamination using 0.12% chlorhexidine oral rinse twice daily from the day before surgery until postoperative day 3.

Group Type EXPERIMENTAL

oral chlorhexidine decontamination

Intervention Type OTHER

For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.

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

Patients in this group 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. They will also receive routine oral care which is routine toothbrushing twice daily.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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immunonutrition supplement of ORAL IMPACT™

For intervention group, patients will take immunonutrition supplement after recruitment until the day before surgery.

Intervention Type DIETARY_SUPPLEMENT

oral chlorhexidine decontamination

For intervention group, patients will use 0.12% chlorhexidine for oral rinse twice daily from the day before surgery until 3 days after surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. age≥65 years;
2. undergoing major non-cardiac surgery;
3. scheduled for general anesthesia and endotracheal intubation;
4. American Society of Anesthesiologists (ASA) physical status classification I-IV;
5. with intermediate to high risk of respiratory complications assessed by Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score;
6. informed 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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No