Spinal Cord Injury, AcuteNCT03661294
Investigating the Energy Expenditure of Acute Spinal Cord Injured Patients
A study testing GE Healthcare Metabolic Oxygenator in people with Spinal Cord Injury, Acute, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
It is recognised that weight gain is a common problem in patients with a spinal cord injury and can lead to an increased incidence of metabolic syndrome. Weight gain is thought to be attributed to excess calorie intake, reduction in energy requirements and / or a reduction in exercise. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Acute
- What is being tested?
- GE Healthcare Metabolic Oxygenator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Aug 2015to 31 Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18+ years old inclusive
- Traumatic and non-traumatic tetraplegic or paraplegic patient following acute SCI injury
- First referral to the Sheffield Spinal Injuries Centre
- Pressure ulcer(s) category 1 and/or 2 or normal skin
- Be able to provide written informed consent or verbal consent in the presence of an independent witness
- Ventilated patients without sedation
- Enterally fed patients
Who cannot join
- Aged less than 18 years old
- Lack the mental capacity to consent
- Pressure ulcer(s) category 3 and/or 4
- Previously had or currently have metabolic syndrome
- Previously had or currently have diabetes
- Current medication includes either a stimulant(s) and/or depressant(s) e.g. steroids, anti-depressants
Show all 10Show fewer
- MRSA bacterium positive
- Previously had or currently has an eating disorder
- Ventilated patients with sedation
- Currently participating in another research study which may have an impact on the study or patient safety and well-being.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study to Investigate the Energy Expenditure of Acute Spinal Cord Injured Patients at Different Stages of Rehabilitation
It is recognised that weight gain is a common problem in patients with a spinal cord injury and can lead to an increased incidence of metabolic syndrome. Weight gain is thought to be attributed to excess calorie intake, reduction in energy requirements and / or a reduction in exercise. However, further understanding of this energy imbalance needs to be addressed.
This feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of 15 paraplegic and 15 tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study.
Read the detailed description
Introduction:
There are an estimated 40,000 people living with a Spinal Cord Injury (SCI) in the UK alone (http://www.apparelyzed.com/statistics.html). Although there have been improvements in medical care, mortality rates are still elevated compared to the able-bodied population. The most common underlying and contributing causes of death in SCI patients are diseases of the circulatory and respiratory system.
It is recognised that weight gain is a common problem in patients with a SCI, typically occurring within the first year of rehabilitation and continuing life long. SCI patients have been shown to have an increased fat mass, waist circumference and altered lipid profile. Obesity in SCI patients can lead to an increased incidence of metabolic syndrome.
Patient weight gain is thought to be attributed to the reduction in energy expenditure compared to pre-injury levels, the loss of voluntary muscle use below the spinal cord lesion and reduction in lean tissue mass. It has been shown that the basal metabolic rate (BMR) of SCI patients is lower than predicted, with the greatest difference being for high tetraplegics. Findings suggest there is an overestimation of energy requirements in a small population of medically stable SCI patients. In addition, SCI calorie and protein intake is high in this patient population, suggesting that patients are also exceeding their nutritional recommendations. Excess calorie intake, reduction in energy requirement and / or a reduction in exercise will predispose the SCI patient to weight gain and obesity. Further understanding of this energy imbalance needs to be addressed.
This single centre feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of paraplegic and tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study on energy expenditure and development of metabolic syndrome in SCI patients. In addition, the feasibility study will address patient recruitment rates and reasons for withdrawal from the study and highlight any practicality issues with study conduct.
Recruitment:
15 acute paraplegic and 15 acute tetraplegic (ventilated and non-ventilated) inpatients will recruited.
Methodology:
The following procedures will be performed at bed rest, early mobilisation and hospital discharge:
Measurement of Actual Energy Expenditure Actual resting energy expenditure (REE) is determined by measuring the oxygen consumption and carbon dioxide production of a patient at rest using the GE Healthcare metabolic oxygenator. During the test, the individual is interfaced with a metabolic measurement system by means of a facemask. For ventilated patients, the monitor will be used with a cuffed tracheostomy tube.
Software will be used to calculate the respiratory quotient (RQ).
Calculating Predicted Energy Requirements Henry equations are used to predict the basal metabolic rate. Adjustments are made based on metabolic stress associated with illness and for obese individuals.
Determining Dietary Intake The patient's dietary intake will be reported using the standard hospital food charts. These will be completed for all food and fluids taken providing an indication of portion sizes. The charts will be kept for 3 consecutive days at each time point and is based on a pragmatic approach to improve accuracy of completion over a short period of time whilst still providing daily variations in intake. Data will be collected so that it covers at least one day of a weekend.
Anthropometric Measurements
Anthropometric measurements will be taken to determine patient body fat and muscle. The following parameters will be measured:
- Mid Upper Arm Circumference (MUAC)
- Tricep Skinfold Thickness (TSF)
Mid Arm Muscle Circumference (MAMC) will be calculated using the equation:
MAMC = MUAC - 3.14 x TSF
Metabolic Syndrome Measurements
The following will be measured:
- Weight
- Height
- BMI Calculation
- Blood Pressure
- Waist Circumference
- Fasting glucose, HDL, triglycerides
- Conditions
- Spinal Cord Injury, Acute
- Being tested
- GE Healthcare Metabolic Oxygenator
- Keywords
- Energy, spinal cord injury
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE Healthcare Metabolic OxygenatorDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| GE Healthcare Metabolic Oxygenator | Other | The actual and predicted energy expenditure of tetraplegic (ventilated/non-vent) and paraplegic patients will be measured at three time points during the patient's rehabilitation in hospital. Receives: Diagnostic Test: GE Healthcare Metabolic Oxygenator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sample size for definitive study
Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Secondary outcomes (9)
Recruitment Period for Definitive Study
Number of patients recruited per year
Measured: 1 year
Predicted Energy Requirements
Basal metabolic rate at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Dietary Intake
Hospital food chart analysis upon hospital admission, at initial mobilisation and hospital discharge
Measured: 1 year
Muscle Measurements
Mid arm muscle circumference measured at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Adipose Tissue Measurements
Waist circumference measured at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Lipid Measurements
Fasting blood lipid profile measured at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
BMI Measurements
BMI calculated from height and weight measurements at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Blood Pressure Measurements
Blood pressure measured at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Glucose Measurements
Fasting blood glucose measured at hospital admission, initial mobilisation and hospital discharge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start10 Aug 2015
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, AcuteStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia UK Ltd, University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661294
- Sponsor's protocol ID
- STH18054
- Status last verified
- Jun 2022
- First submitted
- 13 Jul 2017
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Investigate the Energy Expenditure of Acute Spinal Cord Injured Patients at Different Stages of Rehabilitation
- ClinicalTrials.gov ID
- NCT03661294
- Acronym / sponsor ID
- STH18054
- Conditions
- Spinal Cord Injury, Acute
- Keywords
- Energy, spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Nutricia UK Ltd, University of Sheffield
- Study start
- 10 Aug 2015 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 7 Sep 2018 (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.
It is recognised that weight gain is a common problem in patients with a spinal cord injury and can lead to an increased incidence of metabolic syndrome. Weight gain is thought to be attributed to excess calorie intake, reduction in energy requirements and / or a reduction in exercise. However, further understanding of this energy imbalance needs to be addressed.
This feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of 15 paraplegic and 15 tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study.
Detailed description
Introduction:
There are an estimated 40,000 people living with a Spinal Cord Injury (SCI) in the UK alone (http://www.apparelyzed.com/statistics.html). Although there have been improvements in medical care, mortality rates are still elevated compared to the able-bodied population. The most common underlying and contributing causes of death in SCI patients are diseases of the circulatory and respiratory system.
It is recognised that weight gain is a common problem in patients with a SCI, typically occurring within the first year of rehabilitation and continuing life long. SCI patients have been shown to have an increased fat mass, waist circumference and altered lipid profile. Obesity in SCI patients can lead to an increased incidence of metabolic syndrome.
Patient weight gain is thought to be attributed to the reduction in energy expenditure compared to pre-injury levels, the loss of voluntary muscle use below the spinal cord lesion and reduction in lean tissue mass. It has been shown that the basal metabolic rate (BMR) of SCI patients is lower than predicted, with the greatest difference being for high tetraplegics. Findings suggest there is an overestimation of energy requirements in a small population of medically stable SCI patients. In addition, SCI calorie and protein intake is high in this patient population, suggesting that patients are also exceeding their nutritional recommendations. Excess calorie intake, reduction in energy requirement and / or a reduction in exercise will predispose the SCI patient to weight gain and obesity. Further understanding of this energy imbalance needs to be addressed.
This single centre feasibility study will initially determine if it is feasible to measure the 'actual' energy requirements of paraplegic and tetraplegic (ventilated and non-ventilated) in-patients during bed rest and rehabilitation following acute SCI. This preliminary data will be compared to 'predicted' energy expenditure levels. The calorie intake and body composition for each patient will be measured as well as factors indicative of metabolic syndrome. The study will initially provide statistical information in order to estimate the sample size required for a future definitive study on energy expenditure and development of metabolic syndrome in SCI patients. In addition, the feasibility study will address patient recruitment rates and reasons for withdrawal from the study and highlight any practicality issues with study conduct.
Recruitment:
15 acute paraplegic and 15 acute tetraplegic (ventilated and non-ventilated) inpatients will recruited.
Methodology:
The following procedures will be performed at bed rest, early mobilisation and hospital discharge:
Measurement of Actual Energy Expenditure Actual resting energy expenditure (REE) is determined by measuring the oxygen consumption and carbon dioxide production of a patient at rest using the GE Healthcare metabolic oxygenator. During the test, the individual is interfaced with a metabolic measurement system by means of a facemask. For ventilated patients, the monitor will be used with a cuffed tracheostomy tube.
Software will be used to calculate the respiratory quotient (RQ).
Calculating Predicted Energy Requirements Henry equations are used to predict the basal metabolic rate. Adjustments are made based on metabolic stress associated with illness and for obese individuals.
Determining Dietary Intake The patient's dietary intake will be reported using the standard hospital food charts. These will be completed for all food and fluids taken providing an indication of portion sizes. The charts will be kept for 3 consecutive days at each time point and is based on a pragmatic approach to improve accuracy of completion over a short period of time whilst still providing daily variations in intake. Data will be collected so that it covers at least one day of a weekend.
Anthropometric Measurements
Anthropometric measurements will be taken to determine patient body fat and muscle. The following parameters will be measured:
- Mid Upper Arm Circumference (MUAC)
- Tricep Skinfold Thickness (TSF)
Mid Arm Muscle Circumference (MAMC) will be calculated using the equation:
MAMC = MUAC - 3.14 x TSF
Metabolic Syndrome Measurements
The following will be measured:
- Weight
- Height
- BMI Calculation
- Blood Pressure
- Waist Circumference
- Fasting glucose, HDL, triglycerides
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GE Healthcare Metabolic Oxygenator | Other | Diagnostic Test: GE Healthcare Metabolic OxygenatorThe actual and predicted energy expenditure of tetraplegic (ventilated/non-vent) and paraplegic patients will be measured at three time points during the patient's rehabilitation in hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18+ years old inclusive
- Traumatic and non-traumatic tetraplegic or paraplegic patient following acute SCI injury
- First referral to the Sheffield Spinal Injuries Centre
- Pressure ulcer(s) category 1 and/or 2 or normal skin
- Be able to provide written informed consent or verbal consent in the presence of an independent witness
Key exclusion criteria (10 listed)
- Aged less than 18 years old
- Lack the mental capacity to consent
- Pressure ulcer(s) category 3 and/or 4
- Previously had or currently have metabolic syndrome
- Previously had or currently 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 |
|---|---|---|
| GE Healthcare Metabolic Oxygenator | Diagnostic test | GE Healthcare Metabolic Oxygenator |
Primary outcome
Sample size for definitive study
Time frame: 1 year
Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge
9 secondary outcomes
Recruitment Period for Definitive Study
Time frame: 1 year
Predicted Energy Requirements
Time frame: 1 year
Dietary Intake
Time frame: 1 year
Muscle Measurements
Time frame: 1 year
Adipose Tissue Measurements
Time frame: 1 year
Lipid Measurements
Time frame: 1 year
BMI Measurements
Time frame: 1 year
Blood Pressure Measurements
Time frame: 1 year
Glucose Measurements
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GE Healthcare Metabolic Oxygenator in people with Spinal Cord Injury, Acute, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 9 Jun 2022. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sample size for definitive study (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.