Diet, Carbohydrate LoadingNCT05778487
Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery
A study testing Gatorade Thirst Quencher in people with Diet, Carbohydrate Loading, run by Horizon Health Network at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Diet, Carbohydrate Loading
- What is being tested?
- Gatorade Thirst Quencher
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jul 2022to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Kevan Kostynski contact
Canada1 site, 1 recruiting
- Recruiting
Canada East Spine Centre at Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2
Canada East Spine Centre, 506-566-1451, cescresearch@gmail.com
Kevan Kostynski, kevan.kostynski@dal.ca
About this study
Official title: The Effects of Preoperative Carbohydrate Loading on Elderly Patients Undergoing Orthopaedic Spine Surgery - A CSORN Study
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.
Read the detailed description
Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Because of this, preoperative carbohydrate loading has been included in the Enhanced Recovery After Surgery (ERAS) and Enhanced Recovery Canada (ERC) guidelines across a variety of surgical specialities; however, a gap in the literature remains within the field of orthopaedic surgery, specifically in cervical and thoracolumbar spine surgeries. 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. This is an ambispective research study including elderly patients from the Canadian Spine Outcomes and Research Network (CSORN) registry, who have either recently undergone, or are scheduled to undergo, an orthopaedic cervical or thoracolumbar spine surgery (fusion, decompression, or discectomy). The control group will include retrospectively recruited patients, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink up to 2 hours prior to surgery. Groups will also be matched based on various patient demographic and surgical variables. LOS in hospital and perioperative patient adverse events are the outcome measurements of interest. Patient and surgical variables will also be collected for comparison. 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
- Being tested
- Gatorade Thirst Quencher
- Keywords
- Carbohydrate Loading, Orthopaedics, Elderly, Spine, Cervical, Thoracolumbar, Fusion, Decompression, Discectomy, Gatorade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gatorade Thirst QuencherDietary supplement
Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Gatorade Thirst Quencher |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay (LOS) in Hospital
How long (hours) are the patients staying in hospital for?
Measured: 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
Do the patients experience any adverse events in hospital such as pain, nausea, vomiting?
Measured: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start13 Jul 2022
- Primary completionJul 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diet, Carbohydrate LoadingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Small, MD, Principal investigator, Canada East Spine Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778487
- Sponsor's protocol ID
- HorizonHN
- Status last verified
- Mar 2023
- First submitted
- 22 Jun 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data cannot be shared publicly because of legal and ethic restrictions. Data from this study are available (contact cescresearch@gmail.com) for researchers who meet the criteria for access to confidential data.
Publications
Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.
PubMed 21781358Yang 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.
PubMed 23569671Altman 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.
PubMed 31036609Harsten 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.
PubMed 22450530Wainwright 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.
PubMed 32056486Debono 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.
PubMed 33444664Baek 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.
PubMed 29652932Singh 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.
PubMed 34044894Ljungqvist 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.
PubMed 28097305Ackerman 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.
PubMed 31637778
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preoperative Carbohydrate Loading on Elderly Patients Undergoing Orthopaedic Spine Surgery - A CSORN Study
- ClinicalTrials.gov ID
- NCT05778487
- Acronym / sponsor ID
- HorizonHN
- Conditions
- Diet, Carbohydrate Loading
- Keywords
- Carbohydrate Loading, Orthopaedics, Elderly, Spine, Cervical, Thoracolumbar, Fusion, Decompression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Because of this, preoperative carbohydrate loading has been included in the Enhanced Recovery After Surgery (ERAS) and Enhanced Recovery Canada (ERC) guidelines across a variety of surgical specialities; however, a gap in the literature remains within the field of orthopaedic surgery, specifically in cervical and thoracolumbar spine surgeries. 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. This is an ambispective research study including elderly patients from the Canadian Spine Outcomes and Research Network (CSORN) registry, who have either recently undergone, or are scheduled to undergo, an orthopaedic cervical or thoracolumbar spine surgery (fusion, decompression, or discectomy). The control group will include retrospectively recruited patients, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink up to 2 hours prior to surgery. Groups will also be matched based on various patient demographic and surgical variables. LOS in hospital and perioperative patient adverse events are the outcome measurements of interest. Patient and surgical variables will also be collected for comparison. 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: Gatorade Thirst QuencherStandard 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gatorade Thirst QuencherGatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml) | Dietary supplement | Carbohydrate Group |
Primary outcome
Length of Stay (LOS) in Hospital
Time frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
How long (hours) are the patients staying in hospital for?
1 secondary outcome
Perioperative Patient Adverse Events
Time frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 21781358Kratzing C. Pre-operative nutrition and carbohydrate loading. Proc Nutr Soc. 2011 Aug;70(3):311-5. doi: 10.1017/S0029665111000450.
- Background: PubMed 23569671Yang 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.
- Background: PubMed 31036609Altman 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.
- Background: PubMed 22450530Harsten 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.
- Background: PubMed 32056486Wainwright 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.
- Background: PubMed 33444664Debono 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.
- Background: PubMed 29652932Baek 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.
- Background: PubMed 34044894Singh 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.
- Background: PubMed 28097305Ljungqvist 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.
- Background: PubMed 31637778Ackerman 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.
- Individual participant dataSharing planned: No. Data cannot be shared publicly because of legal and ethic restrictions. Data from this study are available (contact cescresearch@gmail.com) for researchers who meet the criteria for access to confidential data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevan Kostynski contact
Chris Small, MD principal investigator
Canada East Spine Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gatorade Thirst Quencher in people with Diet, Carbohydrate Loading, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Canada East Spine Centre (506-566-1451, cescresearch@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay (LOS) in Hospital (time frame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778487, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.