Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Malnutrition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451538
• Other study ID #: 2019-322
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2020
• Est. completion date: July 2025

Study information

• Verified date: July 2021
• Source: Peking University First Hospital
• Contact: Dong-Mei Ni, MD
• Phone: 8610 83575138
• Email: dongmeini[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 970
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly Patients
• Fractures, Bone
• Hip Fractures
• Malnutrition
• Nutritional Intervention
• Perioperative Outcomes
• Survival

Intervention

Dietary Supplement:
• Nutritional intervention group
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).
• Control group
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

Locations

Country	Name	City	State
China	Fourth Medical Center of PLA General Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Tianjin Orthopedic Hospital	Tianjin	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
Peking University First Hospital	The Forth Medical Center of PLA General Hospital, Tianjin Orthopedic Hospital

Country where clinical trial is conducted

China, 

References & Publications (42)

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* Note: There are 42 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Subjective sleep quality.	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
Primary	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	Intensive care unit admission after surgery	Intensive care unit admission after surgery	Within 24 hours after surgery
Secondary	Length of intensive care unit stay after surgery	Length of intensive care unit stay after surgery	Up to 30 days after surgery
Secondary	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
Secondary	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
Secondary	Length of hospital stay after surgery	Length of hospital stay after surgery	Up to 30 days after surgery.
Secondary	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.
Secondary	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.