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The trial was stopped prematurely due to slow recruitment.
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| Name | Class |
|---|---|
| Fourth Medical Center of PLA General Hospital | OTHER |
| Tianjin Orthopedic Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional intervention group | Experimental | 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). |
|
| Control group | Placebo Comparator | Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional intervention group | 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). |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity. | Pain intensity is assessed twice daily (8:00-10:00, 18:00-20:00) with the numeric rating scale (NRS; which is an 11-point scale whereas 0=no pain and 10=the worst pain). | During the first 5 days after surgery |
| Subjective sleep quality. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dong-Xin Wang, MD, PhD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100034 | China | ||
| Fourth Medical Center of PLA General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19826027 | Background | Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462. | |
| 22150501 | Background | Membership of the Working Party; Griffiths R, Alper J, Beckingsale A, Goldhill D, Heyburn G, Holloway J, Leaper E, Parker M, Ridgway S, White S, Wiese M, Wilson I. Management of proximal femoral fractures 2011: Association of Anaesthetists of Great Britain and Ireland. Anaesthesia. 2012 Jan;67(1):85-98. doi: 10.1111/j.1365-2044.2011.06957.x. |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| Control group | Dietary Supplement | Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). |
|
| 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. |
Subjective sleep quality is assessed once daily (8:00-10:00) with the numeric rating scale (NRS; which is an 11-point scale whereas 0=the best sleep and 10=the worst sleep).
| During the first 5 days after surgery |
| Beijing |
| Beijing Municipality |
| 100048 |
| China |
| Tianjin Orthopedic Hospital | Tianjin | Tianjin Municipality | China |
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| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D008722 | Methods |