Nutritional support for elderly patients after hip fracture surgery
Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
This study is testing if giving extra nutrition to older patients before and after hip fracture surgery can help them recover better and live longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 970 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing and 2 other locations) |
| Trial ID | NCT04451538 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of perioperative nutritional intervention on elderly patients who are malnourished or at risk of malnutrition and are scheduled for hip-fracture surgery. It aims to determine whether providing nutritional support before and after surgery can reduce complications such as delirium and improve long-term survival outcomes. The study will compare a group receiving nutritional intervention to a control group not receiving this support. The research is based on the premise that improving nutritional status can lead to better clinical outcomes in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 70 and older who are hospitalized for hip fractures and classified as malnourished or at risk of malnutrition.
Not a fit: Patients with severe comorbid conditions or those unable to communicate or eat due to gastrointestinal issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce postoperative complications and improve survival rates for elderly patients undergoing hip fracture surgery.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing and 2 other locations
- Peking University First Hospital — Beijing, Beijing, China (Recruiting)
- Fourth Medical Center of PLA General Hospital — Beijing, Beijing, China (Recruiting)
- Tianjin Orthopedic Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
Study contacts
- Principal investigator: Dong-Xin Wang, MD, PhD — Peking University First Hospital
- Study coordinator: Dong-Mei Ni, MD
- Email: dongmeini@hotmail.com
- Phone: 8610 83575138
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.