Clincosm LogoSign in Get a demo

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Sponsor
Peking University First Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04451538
Collaborator
The Forth Medical Center of PLA General Hospital (Other), Tianjin Orthopedic Hospital (Other)
970
Enrollment
3
Locations
2
Arms
54.1
Anticipated Duration (Months)
323.3
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Nutritional intervention group
  • Dietary Supplement: Control group
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
970 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
Actual Study Start Date :
Dec 28, 2020
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Incidence of delirium or non-delirium complications after surgery [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.

Secondary Outcome Measures

  1. Intensive care unit admission after surgery [Within 24 hours after surgery]

    Intensive care unit admission after surgery

  2. Length of intensive care unit stay after surgery [Up to 30 days after surgery]

    Length of intensive care unit stay after surgery

  3. Incidence of organ injury within 5 days after surgery [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).

  4. Incidence of non-delirium complications after surgery [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.

  5. Length of hospital stay after surgery [Up to 30 days after surgery.]

    Length of hospital stay after surgery

  6. Cognitive function at 30 days after surgery [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.

  7. Quality of life at 30 days after surgery [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.

Other Outcome Measures

  1. Pain intensity. [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).

  2. Subjective sleep quality. [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
70 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University First Hospital Beijing Beijing China 100034
2 Fourth Medical Center of PLA General Hospital Beijing Beijing China 100048
3 Tianjin Orthopedic Hospital Tianjin Tianjin China

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT04451538
Other Study ID Numbers:
  • 2019-322
First Posted:
Jun 30, 2020
Last Update Posted:
Jul 16, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital
Elderly patients
Malnutrition
Hip Fractures
Nutritional intervention
Perioperative outcomes
Long-term survival
Additional relevant MeSH terms:
Malnutrition
Fractures, Bone
Hip Fractures

Study Results

No Results Posted as of Jul 16, 2021