Protein and Carbohydrate Loading in Elderly With Hip Fractures

NCT04614181 | Completed

• 1 other identifier: 2020629-8833 56379
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Pre-operative carbohydrate and protein loading among older people with hip fractures could potentially influence patient outcomes. This mode of intervention has seen good outcomes in a general surgical setting as part of its enhanced recovery pathway. However, its effectiveness and ease of implementation in a hip fracture setting is uncertain. This study aims to study the feasibility of protein and carbohydrate loading as part of hip fracture management compared to usual care.

Conditions

Hip Fractures

Outcome Measures

Primary Outcomes (4)

• The number of participants recruitment

  How many participants willing to be recruited, screening to recruitment rate

  6 months

• The number of participants that adhered to nutritional loading

  How many participants adhered to the the total treatment drinks

  6 months

• The attrition rate of participants recruited into the study

  How many participants dropped out or had missing data

  6 months

• Safety profile: How many participants had an adverse reaction

  How many participants had an adverse reaction

  6 months

Secondary Outcomes (5)

• Prevalence of post-operative nausea and/or vomiting

  6 months

• Severity of post-operative pain

  6 months

• Length of stay

  6 months

• Change in muscle strength

  6 months

• Prevalence of post-operative complications

  6 months

Study Arms (2)

Carbohydrate and protein loading

EXPERIMENTAL

Nestle Resource drink

Dietary Supplement: Nestle Resource drink

Usual care

ACTIVE COMPARATOR

Usual fracture care as determined by clinical team

Other: Usual care

Interventions

Nestle Resource drink DIETARY_SUPPLEMENT

Beverage (Nestle RESOURCE). Each serving is 237ml containing 53.6g of carbohydrate and 9g of protein. Intervention group will consume two servings of the carbohydrate beverage (53.6g each, total of approximately 100g) on the day before surgery and one serving up to 6 hours prior to scheduled surgery time.

Carbohydrate and protein loading

Usual care OTHER

Usual fracture care as determined by clinical team

Usual care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• All patients planned for semi-emergency hip surgery (total arthroplasty, hemiarthroplasty, internal fixation)
• Aged 65 years and above
• ASA 1-3 (ASA Physical Status Classification System)

You may not qualify if:

• Patients undergoing hip surgery of emergency nature (inadequate time for recruitment and pre-operative intervention)
• Peri-prosthetic hip fracture and fracture due to underlying malignancy
• Revision hip surgery
• Participation in another nutritional program
• Diabetes mellitus
• Intolerance to carbohydrate drinks
• Gastric reflux, risk of aspiration, dysphagia
• Severe cognitive impairment and delirium

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Medicine, University of Malaya

Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

• Yap KS, Loh PS, Foong YX, Mok CZ, Ong T, Khor HM. A feasibility study on preoperative carbohydrate loading in older patients undergoing hip fracture surgery. BMC Geriatr. 2024 May 6;24(1):401. doi: 10.1186/s12877-024-04958-7.

  PMID: 38711010 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: November 3, 2020
• Study Start: November 4, 2020
• Primary Completion: June 29, 2021
• Study Completion: December 30, 2021
• Last Updated: May 20, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)