NCT03728400

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1.3 years

First QC Date

October 31, 2018

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • frequency of undernutrition at the entrance

    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.

    Day 1

Secondary Outcomes (2)

  • Modified Rankin scale

    3 months

  • Recurrence rate of ischemic or haemorrhagic stroke

    3 months

Study Arms (1)

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.

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in Neurovascular Intensive care Unit following a stroke

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Marie P BRUANDET, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2018

First Posted

November 2, 2018

Study Start

May 29, 2018

Primary Completion

August 30, 2019

Study Completion

December 30, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations