NCT03661294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

4.2 years

First QC Date

July 13, 2017

Last Update Submit

June 8, 2022

Conditions

Spinal Cord Injury, Acute

Keywords

Energy, spinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Sample size for definitive study

    Standard deviation of Resting Energy Expenditure measurements at hospital admission, initial mobilisation and hospital discharge

    1 year

Secondary Outcomes (9)

  • Recruitment Period for Definitive Study

    1 year

  • Predicted Energy Requirements

    1 year

  • Dietary Intake

    1 year

  • Muscle Measurements

    1 year

  • Adipose Tissue Measurements

    1 year

  • +4 more secondary outcomes

Study Arms (1)

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.

Diagnostic Test: GE Healthcare Metabolic Oxygenator

Interventions

GE Healthcare Metabolic OxygenatorDIAGNOSTIC_TEST
GE Healthcare Metabolic Oxygenator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

September 7, 2018

Study Start

August 10, 2015

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

June 9, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)