Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery
NCT ID: NCT04451538
Last Updated: 2025-08-05
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
TERMINATED
Clinical Phase
NA
Total Enrollment
30 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-12-28
Study Completion Date
2021-04-02
Brief Summary
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Hip fracture is one of the most frequently occurred injury in the elderly and usually requires surgical treatment. Malnutrition is common in elderly patients with hip fracture and is associated with worse outcomes. This study is designed to test the hypothesize that, in elderly patients with malnutrition or at risk of malnutrition and scheduled for hip-fracture surgery, perioperative nutritional intervention may reduce early complications and improve long-term survival.
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Detailed Description
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Elderly patients with hip fracture have a high rate of malnutrition. In a cohort study of hip fracture patients aged 70 years or older, 18.8% have malnutrition and 44.6% are at risk of malnutrition. Increasing evidence suggest that preoperative nutritional status has a significant impact on clinical outcomes of elderly patients following surgery. For example, preoperative malnutrition or risk of malnutrition is associated with increased delirium, increased non-delirium complications, prolonged hospital stay, high mortality, and even worse long-term survival after surgery. We speculate that perioperative nutritional intervention may reduce postoperative delirium and improve early and long-term clinical outcomes in elderly hip-fracture patients. The purpose of this study is to observe the effect of perioperative nutritional intervention on early postoperative delirium and complications as well as long-term survival in the patients with malnutrition or at risk of malnutrition who are scheduled for hip-fracture surgery.
Conditions
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Elderly Patients
Malnutrition
Hip Fractures
Nutritional Intervention
Perioperative Outcomes
Survival
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
NONE
Study Groups
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Nutritional intervention group
Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g \[12 spoon, 500 kcal\]/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g \[12 spoon, 440 kcal\]/day, twice a day).
Group Type
EXPERIMENTAL
Nutritional intervention group
Intervention Type
DIETARY_SUPPLEMENT
Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g (12 spoons, 500 kcal)/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g \[12 spoons, 440 kcal\]/day, twice a day).
Control group
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
Group Type
PLACEBO_COMPARATOR
Control group
Intervention Type
DIETARY_SUPPLEMENT
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
Interventions
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Nutritional intervention group
Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g (12 spoons, 500 kcal)/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g \[12 spoons, 440 kcal\]/day, twice a day).
Intervention Type
DIETARY_SUPPLEMENT
Control group
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
Intervention Type
DIETARY_SUPPLEMENT
Eligibility Criteria
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Inclusion Criteria
* Age ≥70 years old;
* Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
* Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
* Provide written informed consents.
* Hospitalized for hip fracture, scheduled to undergo hip-fracture surgery within 48 hours;
* Classified as malnutrition or at risk of malnutrition according to the short form mini-nutrition assessment (MNA-SF);
* Provide written informed consents.
Exclusion Criteria
* Pathological fracture;
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
* Unable to communicate due to coma, severe dementia, or language barrier;
* Unable to eat due to any disease in the gastrointestinal system;
* Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;
* Preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.);
* Other conditions that are considered unsuitable for study participation.
* History of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis before surgery;
* Unable to communicate due to coma, severe dementia, or language barrier;
* Unable to eat due to any disease in the gastrointestinal system;
* Severe hepatic dysfunction (Child-Pugh class C), renal failure (requirement of renal replacement therapy), respiratory failure (requirement of respiratory support), cardiac insufficiency (New York Heart Association classification ≥IV), or American Socisty of Anesthesiologists classification ≥IV;
* Preexisting organ injury before surgery (delirium, acute kidney injury, myocardial injury, etc.);
* Other conditions that are considered unsuitable for study participation.
Minimum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The Forth Medical Center of PLA General Hospital
UNKNOWN
Sponsor Role
collaborator
Tianjin Orthopedic Hospital
UNKNOWN
Sponsor Role
collaborator
Peking University First Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Dong-Xin Wang
Professor and Chairman, Department of Anesthesiology and Critical Care Medicine
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Dong-Xin Wang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, China
Site Status
Fourth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Site Status
Tianjin Orthopedic Hospital
Tianjin, Tianjin Municipality, China
Site Status
Countries
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China
References
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Other Identifiers
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2019-322
Identifier Type: -
Identifier Source: org_study_id
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