Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Peking University

Status: Terminated

Conditions: Hip Fractures; Survival; Perioperative Outcomes; Malnutrition; Nutritional Intervention; Elderly Patients

Treatments: Dietary Supplement: Nutritional intervention group; Dietary Supplement: Control group

Study type: Interventional

Funder types: Other

Identifiers

NCT04451538

2019-322

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups, including a placebo group

Nutritional intervention group

Experimental group

Description:

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).

Treatment:

Dietary Supplement: Nutritional intervention group

Control group

Placebo Comparator group

Description:

Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

Treatment:

Dietary Supplement: Control group