Malnutrition Clinical Trial
Official title:
Impact of Perioperative Nutritional Intervention on Perioperative Outcomes of Elderly Patients Having Hip Fracture Surgery: A Randomized Control Trial
NCT number | NCT04451538 |
Other study ID # | 2019-322 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 28, 2020 |
Est. completion date | July 2025 |
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.
Status | Recruiting |
Enrollment | 970 |
Est. completion date | July 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Fourth Medical Center of PLA General Hospital | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | Tianjin Orthopedic Hospital | Tianjin | Tianjin |
Lead Sponsor | Collaborator |
---|---|
Peking University First Hospital | The Forth Medical Center of PLA General Hospital, Tianjin Orthopedic Hospital |
China,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain intensity. | 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 | |
Other | Subjective sleep quality. | 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 | |
Primary | 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. | Up to 30 days after surgery | |
Secondary | Intensive care unit admission after surgery | Intensive care unit admission after surgery | Within 24 hours after surgery | |
Secondary | Length of intensive care unit stay after surgery | Length of intensive care unit stay after surgery | Up to 30 days after surgery | |
Secondary | 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). | Up to 5 days after surgery | |
Secondary | 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. | Up to 30 days after surgery | |
Secondary | Length of hospital stay after surgery | Length of hospital stay after surgery | Up to 30 days after surgery. | |
Secondary | 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. | At 30 days after surgery. | |
Secondary | 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. | At 30 days after surgery. |
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