Investigating the Energy Expenditure of Acute Spinal Cord Injured Patients
Primary Purpose
Spinal Cord Injury, Acute
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
GE Healthcare Metabolic Oxygenator
Sponsored by
About this trial
This is an interventional other trial for Spinal Cord Injury, Acute focused on measuring Energy, spinal cord injury
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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.
Sites / Locations
- Northern General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GE Healthcare Metabolic Oxygenator
Arm Description
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.
Outcomes
Primary Outcome Measures
Sample size for definitive study
Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge
Secondary Outcome Measures
Recruitment Period for Definitive Study
Number of patients recruited per year
Predicted Energy Requirements
Basal metabolic rate at hospital admission, initial mobilisation and hospital discharge
Dietary Intake
Hospital food chart analysis upon hospital admission, at initial mobilisation and hospital discharge
Muscle Measurements
Mid arm muscle circumference measured at hospital admission, initial mobilisation and hospital discharge
Adipose Tissue Measurements
Waist circumference measured at hospital admission, initial mobilisation and hospital discharge
Lipid Measurements
Fasting blood lipid profile measured at hospital admission, initial mobilisation and hospital discharge
BMI Measurements
BMI calculated from height and weight measurements at hospital admission, initial mobilisation and hospital discharge
Blood Pressure Measurements
Blood pressure measured at hospital admission, initial mobilisation and hospital discharge
Glucose Measurements
Fasting blood glucose measured at hospital admission, initial mobilisation and hospital discharge
Full Information
NCT ID
NCT03661294
First Posted
July 13, 2017
Last Updated
June 8, 2022
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Nutricia UK Ltd, University of Sheffield
1. Study Identification
Unique Protocol Identification Number
NCT03661294
Brief Title
Investigating the Energy Expenditure of Acute Spinal Cord Injured Patients
Official Title
Feasibility Study to Investigate the Energy Expenditure of Acute Spinal Cord Injured Patients at Different Stages of Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2015 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborators
Nutricia UK Ltd, University of Sheffield
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Acute
Keywords
Energy, spinal cord injury
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GE Healthcare Metabolic Oxygenator
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
GE Healthcare Metabolic Oxygenator
Primary Outcome Measure Information:
Title
Sample size for definitive study
Description
Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Recruitment Period for Definitive Study
Description
Number of patients recruited per year
Time Frame
1 year
Title
Predicted Energy Requirements
Description
Basal metabolic rate at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
Dietary Intake
Description
Hospital food chart analysis upon hospital admission, at initial mobilisation and hospital discharge
Time Frame
1 year
Title
Muscle Measurements
Description
Mid arm muscle circumference measured at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
Adipose Tissue Measurements
Description
Waist circumference measured at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
Lipid Measurements
Description
Fasting blood lipid profile measured at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
BMI Measurements
Description
BMI calculated from height and weight measurements at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
Blood Pressure Measurements
Description
Blood pressure measured at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
Title
Glucose Measurements
Description
Fasting blood glucose measured at hospital admission, initial mobilisation and hospital discharge
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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.
Facility Information:
Facility Name
Northern General Hospital
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating the Energy Expenditure of Acute Spinal Cord Injured Patients
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