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Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

Primary Purpose

Elderly Patients, Malnutrition, Hip Fractures

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nutritional intervention group
Control group
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Elderly Patients focused on measuring Elderly patients, Malnutrition, Hip Fractures, Nutritional intervention, Perioperative outcomes, Long-term survival

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First HospitalRecruiting
  • Fourth Medical Center of PLA General HospitalRecruiting
  • Tianjin Orthopedic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nutritional intervention group

Control group

Arm Description

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).

Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Intensive care unit admission after surgery
Intensive care unit admission after surgery
Length of intensive care unit stay after surgery
Length of intensive care unit stay after surgery
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).
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.
Length of hospital stay after surgery
Length of hospital stay after surgery
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.
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.

Full Information

First Posted
June 26, 2020
Last Updated
July 10, 2021
Sponsor
Peking University First Hospital
Collaborators
The Forth Medical Center of PLA General Hospital, Tianjin Orthopedic Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04451538
Brief Title
Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery
Official Title
Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 28, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
The Forth Medical Center of PLA General Hospital, Tianjin Orthopedic Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Patients, Malnutrition, Hip Fractures, Nutritional Intervention, Perioperative Outcomes, Survival
Keywords
Elderly patients, Malnutrition, Hip Fractures, Nutritional intervention, Perioperative outcomes, Long-term survival

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
970 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nutritional intervention group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutritional intervention group
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control group
Intervention Description
Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
Primary Outcome Measure Information:
Title
Incidence of delirium or non-delirium complications after surgery
Description
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.
Time Frame
Up to 30 days after surgery
Secondary Outcome Measure Information:
Title
Intensive care unit admission after surgery
Description
Intensive care unit admission after surgery
Time Frame
Within 24 hours after surgery
Title
Length of intensive care unit stay after surgery
Description
Length of intensive care unit stay after surgery
Time Frame
Up to 30 days after surgery
Title
Incidence of organ injury within 5 days after surgery
Description
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).
Time Frame
Up to 5 days after surgery
Title
Incidence of non-delirium complications after surgery
Description
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.
Time Frame
Up to 30 days after surgery
Title
Length of hospital stay after surgery
Description
Length of hospital stay after surgery
Time Frame
Up to 30 days after surgery.
Title
Cognitive function at 30 days after surgery
Description
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.
Time Frame
At 30 days after surgery.
Title
Quality of life at 30 days after surgery
Description
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.
Time Frame
At 30 days after surgery.
Other Pre-specified Outcome Measures:
Title
Pain intensity.
Description
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).
Time Frame
During the first 5 days after surgery
Title
Subjective sleep quality.
Description
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).
Time Frame
During the first 5 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Mei Ni, MD
Phone
8610 83575138
Email
dongmeini@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dong-Xin Wang, MD, PhD
Phone
8610 83572784
Email
wangdongxin@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong-Mei Ni, MD
Phone
8610 83575138
Email
dongmeini@hotmail.com
Facility Name
Fourth Medical Center of PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng-Meng Li, MD
Email
mmli2@yahoo.com
Facility Name
Tianjin Orthopedic Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Xu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

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