Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

NCT04451538 | Terminated DMC

• 1 other identifier: 2019-322
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Elderly patients; Malnutrition; Hip Fractures; Nutritional intervention; Perioperative outcomes; Long-term survival

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intensive care unit admission after surgery

  Within 24 hours after surgery

• Length of intensive care unit stay after surgery

  Up to 30 days after surgery

• Incidence of organ injury within 5 days after surgery

  Up to 5 days after surgery

• Incidence of non-delirium complications after surgery

  Up to 30 days after surgery

• Length of hospital stay after surgery

  Up to 30 days after surgery.

Other Outcomes (2)

• Pain intensity.

  During the first 5 days after surgery

• Subjective sleep quality.

  During the first 5 days after surgery

Study Arms (2)

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).

Dietary Supplement: Nutritional intervention group

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).

Dietary Supplement: Control group

Interventions

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).

Nutritional intervention group

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).

Control group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• The Forth Medical Center of PLA General Hospital: collaborator
• Tianjin Orthopedic Hospital: collaborator

Study Sites (3)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Fourth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, 100048, China

Location

Tianjin Orthopedic Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (42)

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MeSH Terms

Conditions

Malnutrition; Hip Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: June 26, 2020
• First Posted: June 30, 2020
• Study Start: December 28, 2020
• Primary Completion: March 2, 2021
• Study Completion: April 2, 2021
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)