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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

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).

Condition or disease
Stroke

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.

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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : August 30, 2019
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients hospitalized in Neurovascular Intensive care Unit following a stroke
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728400


Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Investigators
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Principal Investigator: Marie P BRUANDET, MD Groupe Hospitalier Paris Saint Joseph
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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT03728400    
Other Study ID Numbers: DENUTRITION USINV
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders