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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

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

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

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

NCT ID

NCT04451538

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

Time Frame

At 30 days after surgery.

Title

Quality of life at 30 days after surgery

Description

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

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

dongmeini@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dong-Xin Wang, MD, PhD

Phone

8610 83572784

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

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

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

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Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

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