Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Study Overview
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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.

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.

Official Title
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Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial

Conditions
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Elderly Patients, Malnutrition, Hip Fractures, Nutritional Intervention, Perioperative Outcomes, Survival

Intervention / Treatment
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* Dietary Supplement: Nutritional intervention group
* Dietary Supplement: Control group


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional intervention group<br>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). | Dietary Supplement: Nutritional intervention group<br>* 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).<br>|
| Placebo Comparator: Control group<br>Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). | Dietary Supplement: Control group<br>* Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of delirium or non-delirium complications after surgery | Delirium is assessed twice daily with Confusion Assessment Method (CAM) or CAM for the Intensive Care Unit (CAM-ICU) during the first 5 days after surgery. Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery. | Up to 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit admission after surgery | Intensive care unit admission after surgery | Within 24 hours after surgery | 
| Length of intensive care unit stay after surgery | Length of intensive care unit stay after surgery | Up to 30 days after surgery | 
| Incidence of organ injury within 5 days after surgery | Organ injury includes delirium (assessed with CAM/CAM-ICU), acute kidney injury (assessed according to KDIGO [Kidney Disease: Improving Global Outcomes] Criteria), and myocardial injury (cardiac troponin I higher than upper normal limit). | Up to 5 days after surgery | 
| Incidence of non-delirium complications after surgery | Non-delirium complications indicate newly occurred conditions (other than delirium) that are harmful to patients' recovery and required therapeutic intervention within 30 days after surgery. | Up to 30 days after surgery | 
| Length of hospital stay after surgery | Length of hospital stay after surgery | Up to 30 days after surgery. | 
| Cognitive function at 30 days after surgery | Cognitive function is assessed with the Modified Telephone Interview for Cognitive Status (TICS-m) which is a 12-item questionnaire that verbally assesses global cognitive function via telephone. The score ranges from 0 to 50, with higher score indicating better function. | At 30 days after surgery. | 
| Quality of life at 30 days after surgery | Quality of life is assessed with the World Health Organization Quality of Life brief version (WHOQOL-BREF) which is a 24-item questionnaire that assesses the quality of life in physical, psychological, social relationship and environmental domains. The score ranges from 0 to 100 for each domain, with higher score indicating better function. | At 30 days after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative outcomes, Elderly patients, Malnutrition, Hip Fractures, Nutritional intervention, Long-term survival