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Perioperative Oral Decontamination and ImmunoNuTrition (POINT) in Elderly

NCT05971810 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 592

Last updated 2025-01-28

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Complications
  • Pulmonary Complication

Interventions

DIETARY_SUPPLEMENT

immunonutrition supplement of ORAL IMPACT™

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

OTHER

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.

Sponsors & Collaborators

  • Fujian Provincial Hospital

    collaborator OTHER

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • Shenzhen Qianhai Shekou Free Trade Zone Hospital

    collaborator UNKNOWN

  • Ningbo No.2 Hospital

    collaborator OTHER

  • Peking University International Hospital

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Yuguang Huang, Dr · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-23
Primary Completion
2025-08-01
Completion
2025-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971810 on ClinicalTrials.gov