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Follow-up of Malnutrition Screening in USINV (DENUTRITION)

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ClinicalTrials.gov Identifier: NCT03728400
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 2, 2018
Last Update Posted Date April 27, 2021
Actual Study Start Date May 29, 2018
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 31, 2018)
frequency of undernutrition at the entrance [ Time Frame: Day 1 ]
The primary endpoint is the number of patients who have had an assessment of their nutritional status, that is, for whom undernutrition is detected according to the terms proposed in the undernutrition screening procedure: search for previous quantified weight loss, input BMI, albuminemia.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 5, 2018)
  • Modified Rankin scale [ Time Frame: 3 months ]
    The Rankin score will be performed in post stroke consultation, 3 months after inclusion. Rankin scale: 0 no symptoms, 1 No significant disability. Able to carry out all usual activities, despite some symptoms, 2 Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities, 3 Moderate disability. Requires some help, but able to walk unassisted, 4 Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted, 5 Severe disability. Requires constant nursing care and attention, bedridden, incontinent
  • Recurrence rate of ischemic or haemorrhagic stroke [ Time Frame: 3 months ]
    The recurrence of stroke will be collected during the post stroke consultation, 3 months after inclusion.
Original Secondary Outcome Measures
 (submitted: October 31, 2018)
  • Rankin scale [ Time Frame: 3 months ]
    The Rankin score will be performed in post stroke consultation, 3 months after inclusion.
  • Recurrence rate of ischemic or haemorrhagic stroke [ Time Frame: 3 months ]
    The recurrence of stroke will be collected during the post stroke consultation, 3 months after inclusion.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Follow-up of Malnutrition Screening in USINV
Official Title Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit
Brief Summary This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).
Detailed Description The main objective of this project is to assess, prospectively, the frequency of undernutrition at the entrance to the neurovascular intensive care unit and to evaluate the implementation of the undernutrition screening procedure.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients hospitalized in Neurovascular Intensive care Unit following a stroke
Condition Stroke
Intervention Not Provided
Study Groups/Cohorts Patients in neurovascular intensive care
During the patient's hospitalization in neurovascular intensive care unit, the doctor will propose to the patient to take part in this study. If the patient agree, this search will not change the patient's usual support and will not involve any further review.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: December 30, 2019)
66
Original Estimated Enrollment
 (submitted: October 31, 2018)
60
Estimated Study Completion Date November 30, 2021
Actual Primary Completion Date August 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient whose age ≥ 70 years
  • Patient hospitalized in Neurovascular Intensive care Unit following a stroke (infarction or cerebral hematoma)
  • Francophone patient

Exclusion Criteria:

  • Patient hospitalized in Neurovascular Intensive care Unit following a transient ischemic attack
  • Patient whose age ≤ 70 years
  • Patient hospitalized in Neurovascular Intensive care Unit for another reason than neurovascular disease
  • Patient opposing the use of his data
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728400
Other Study ID Numbers DENUTRITION USINV
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Groupe Hospitalier Paris Saint Joseph
Study Sponsor Groupe Hospitalier Paris Saint Joseph
Collaborators Not Provided
Investigators
Principal Investigator: Marie P BRUANDET, MD Groupe Hospitalier Paris Saint Joseph
PRS Account Groupe Hospitalier Paris Saint Joseph
Verification Date April 2021