Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery

NCT05778487 | Unknown

• 1 other identifier: HorizonHN
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Conditions

Diet, Carbohydrate Loading

Keywords

Carbohydrate Loading; Orthopaedics; Elderly; Spine; Cervical; Thoracolumbar; Fusion; Decompression; Discectomy; Gatorade

Outcome Measures

Primary Outcomes (1)

• Length of Stay (LOS) in Hospital

  How long (hours) are the patients staying in hospital for?

  From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.

Secondary Outcomes (1)

• Perioperative Patient Adverse Events

  From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.

Study Arms (2)

Control Group

NO INTERVENTION

Standard of care for dietary instructions only. The control group will consist of retrospectively recruited participants who have recently undergone a successful elective spine surgery, and followed the preoperative nutrition standards for their surgery, as outlined by the research institution's fasting dietary guidelines. Recruitment will include the most recent spine surgeries that meet the inclusion criteria and match prospective patient demographics.

Carbohydrate Group

EXPERIMENTAL

Standard of care for dietary instructions + carbohydrate loading. The carbohydrate (CHO) group will consist of prospectively recruited patients scheduled to undergo an elective spine surgery. These participants will also follow the preoperative nutrition standards, however, in addition, they will be instructed to consume 710ml of a simple, commercial carbohydrate sports drink on the day of their procedure up to 2 hours prior to surgery.

Dietary Supplement: Gatorade Thirst Quencher

Interventions

Gatorade Thirst Quencher DIETARY_SUPPLEMENT

Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)

Carbohydrate Group

Eligibility Criteria

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

You may qualify if:

• Patients must meet the age requirement,
• Have either recently undergone, or are scheduled to undergo an elective cervical or thoracolumbar spine surgery, including fusion, decompression, and discectomy procedures.

You may not qualify if:

• Potential participants will be excluded if they do not meet the age requirements,
• Have had, or will be having, cervical or thoracolumbar fusion, decompression or discectomy revision surgery,
• Are not able to consume the selected carbohydrate drink,
• Do not consent to participation in the research study,
• Or have diabetes.

Sponsors & Collaborators

• Horizon Health Network: lead

Study Sites (1)

Canada East Spine Centre at Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

RECRUITING

Related Publications (10)

• Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.

  PMID: 21781358 BACKGROUND

• Yang R, Wolfson M, Lewis MC. Unique Aspects of the Elderly Surgical Population: An Anesthesiologist's Perspective. Geriatr Orthop Surg Rehabil. 2011 Mar;2(2):56-64. doi: 10.1177/2151458510394606.

  PMID: 23569671 BACKGROUND

• Altman AD, Helpman L, McGee J, Samouelian V, Auclair MH, Brar H, Nelson GS; Society of Gynecologic Oncology of Canada's Communities of Practice in ERAS and Venous Thromboembolism. Enhanced recovery after surgery: implementing a new standard of surgical care. CMAJ. 2019 Apr 29;191(17):E469-E475. doi: 10.1503/cmaj.180635. No abstract available.

  PMID: 31036609 BACKGROUND

• Harsten A, Hjartarson H, Toksvig-Larsen S. Total hip arthroplasty and perioperative oral carbohydrate treatment: a randomised, double-blind, controlled trial. Eur J Anaesthesiol. 2012 Jun;29(6):271-4. doi: 10.1097/EJA.0b013e3283525ba9.

  PMID: 22450530 BACKGROUND

• Wainwright TW et al. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Jun;91(3):363. doi: 10.1080/17453674.2020.1724674. Epub 2020 Feb 14. No abstract available.

  PMID: 32056486 BACKGROUND

• Debono B, Wainwright TW, Wang MY, Sigmundsson FG, Yang MMH, Smid-Nanninga H, Bonnal A, Le Huec JC, Fawcett WJ, Ljungqvist O, Lonjon G, de Boer HD. Consensus statement for perioperative care in lumbar spinal fusion: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Spine J. 2021 May;21(5):729-752. doi: 10.1016/j.spinee.2021.01.001. Epub 2021 Jan 12.

  PMID: 33444664 BACKGROUND

• Baek H, Cho M, Kim S, Hwang H, Song M, Yoo S. Analysis of length of hospital stay using electronic health records: A statistical and data mining approach. PLoS One. 2018 Apr 13;13(4):e0195901. doi: 10.1371/journal.pone.0195901. eCollection 2018.

  PMID: 29652932 BACKGROUND

• Singh SM, Liverpool A, Romeiser JL, Miller JD, Thacker J, Gan TJ, Bennett-Guerrero E. A U.S. survey of pre-operative carbohydrate-containing beverage use in colorectal enhanced recovery after surgery (ERAS) programs. Perioper Med (Lond). 2021 May 28;10(1):19. doi: 10.1186/s13741-021-00187-3.

  PMID: 34044894 BACKGROUND

• Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

  PMID: 28097305 BACKGROUND

• Ackerman RS, Tufts CW, DePinto DG, Chen J, Altshuler JR, Serdiuk A, Cohen JB, Patel SY. How Sweet Is This? A Review and Evaluation of Preoperative Carbohydrate Loading in the Enhanced Recovery After Surgery Model. Nutr Clin Pract. 2020 Apr;35(2):246-253. doi: 10.1002/ncp.10427. Epub 2019 Oct 21.

  PMID: 31637778 BACKGROUND

Study Officials

• Chris Small, MD

  Canada East Spine Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Canada East Spine Centre

CONTACT

506-566-1451; cescresearch@gmail.com

Kevan Kostynski

CONTACT

kevan.kostynski@dal.ca

Study Design

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

Model Details: The control group will include retrospectively recruited patients who did not receive preoperative carbohydrate loading, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink prior to surgery.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: March 21, 2023
• Study Start: July 13, 2022
• Primary Completion: July 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)