Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Nutritional Intervention and Outcomes in Elderly After Hip Fracture Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04451538
Recruitment Status : Not yet recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital

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
Elderly Patients Malnutrition Hip Fractures Nutritional Intervention Perioperative Outcomes Survival Dietary Supplement: Nutritional intervention group Dietary Supplement: Control group Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Intensive care unit admission after surgery [ Time Frame: Within 24 hours after surgery ]
    Intensive care unit admission after surgery

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

  3. 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).

  4. 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.

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

  6. 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.

  7. 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.


Other Outcome Measures:
  1. 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).

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451538


Contacts
Layout table for location contacts
Contact: Dong-Mei Ni, MD 8610 83575138 dongmeini@hotmail.com
Contact: Dong-Xin Wang, MD, PhD 8610 83572784 wangdongxin@hotmail.com

Locations
Layout table for location information
China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034
Contact: Dong-Mei Ni, MD    8610 83575138    dongmeini@hotmail.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
Layout table for investigator information
Principal Investigator: Dong-Xin Wang, MD, PhD Peking University First Hospital
Publications:

Layout table for additonal information
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: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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, Peking University First Hospital:
Elderly patients
Malnutrition
Hip Fractures
Nutritional intervention
Perioperative outcomes
Long-term survival
Additional relevant MeSH terms:
Layout table for MeSH terms
Malnutrition
Fractures, Bone
Hip Fractures
Wounds and Injuries
Nutrition Disorders
Femoral Fractures
Hip Injuries
Leg Injuries