Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

July 10, 2021 updated by: Dong-Xin Wang, Peking University First Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

970

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
      • Beijing, Beijing, China, 100048
        • Recruiting
        • Fourth Medical Center of PLA General Hospital
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Not yet recruiting
        • Tianjin Orthopedic Hospital
        • Contact:
          • Jin Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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 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
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).
Placebo Comparator: Control group
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
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of delirium or non-delirium complications after surgery
Time Frame: Up to 30 days 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care unit admission after surgery
Time Frame: Within 24 hours after surgery
Intensive care unit admission after surgery
Within 24 hours after surgery
Length of intensive care unit stay after surgery
Time Frame: Up to 30 days 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
Time Frame: Up to 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
Incidence of non-delirium complications after surgery
Time Frame: Up to 30 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
Length of hospital stay after surgery
Time Frame: Up to 30 days after surgery.
Length of hospital stay after surgery
Up to 30 days after surgery.
Cognitive function at 30 days after surgery
Time Frame: 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.
Quality of life at 30 days after surgery
Time Frame: 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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity.
Time Frame: During the first 5 days after surgery
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
Subjective sleep quality.
Time Frame: During the first 5 days after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

The Forth Medical Center of PLA General Hospital
Tianjin Orthopedic Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 28, 2020

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

June 26, 2020

First Submitted That Met QC Criteria

June 26, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

July 16, 2021

Last Update Submitted That Met QC Criteria

July 10, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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