Clinical trial NCT04451538: Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery
Official title: Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly Patients
Malnutrition
Hip Fractures
Nutritional Intervention
Perioperative Outcomes
Survival
Keywords: Elderly patients
Malnutrition
Hip Fractures
Nutritional intervention
Perioperative outcomes
Long-term survival
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: The Forth Medical Center of PLA General Hospital
name: Tianjin Orthopedic Hospital
First posted: 2020-06-30
Enrollment: 970
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of delirium or non-delirium complications after surgery
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Intensive care unit admission after surgery
timeFrame: Within 24 hours after surgery
measure: Length of intensive care unit stay after surgery
timeFrame: Up to 30 days after surgery
measure: Incidence of organ injury within 5 days after surgery
timeFrame: Up to 5 days after surgery
measure: Incidence of non-delirium complications after surgery
timeFrame: Up to 30 days after surgery
measure: Length of hospital stay after surgery
timeFrame: Up to 30 days after surgery.
measure: Cognitive function at 30 days after surgery
timeFrame: At 30 days after surgery.
measure: Quality of life at 30 days after surgery
timeFrame: At 30 days after surgery.
Other outcomes:
measure: Pain intensity.
timeFrame: During the first 5 days after surgery
measure: Subjective sleep quality.
timeFrame: During the first 5 days after surgery
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Fourth Medical Center of PLA General Hospital
state: Beijing
city: Tianjin
country: China
facility: Tianjin Orthopedic Hospital
state: Tianjin
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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