Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke

Official title

Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke Pragmatic, Controlled, Multicenter, Cluster-randomized Trial

Overview

This study evaluate the impact of early personalized nutritional management on 1-month mortality after acute stroke. In the randomised centres of the interventional group (early personalized nutritional management), each patient will be assessed by a dietician within 2 days of stroke. Any swallowing problems are screened, and any barriers to eating are identified before dietary support. Patient's food intakes are recorded until the 7th day post-acute to assess their energy intake. Depending on patient's nutritional objectives, a reinforced feeding strategy comprising 2 levels is put in place, in order to prevent malnutrition: in level 1, the dietician tries to meet nutritional requirements orally, while in level 2 he can recourse to artificial nutrition in the event of failure or inability to meet requirements with oral intake alone. This strategy is started immediately after the initial assessment. Intakes are reassessed every 24 to 48 hours by the dietician in order to adapt the nutritional strategy as quickly as possible in order to cover the patient's personnalized nutritional needs. No change in practice was required of the randomised centres in the control group. All patients will be contacted by telephone 30 days after stroke to collect parts of the assessment criteria, while the other criteria will be collected directly from the patient's computerised medical record. Three months after stroke, an evaluation of quality of life and modified Rankin test will be performed. Our hypothesis is that the implementation of an individualized management of early nutritional support, aimed at compensating for the decrease in intake associated with the disease, would reduce mortality at 30 days in patients hospitalised for stroke.

Interventions

• Dietary supplement Early nutritional management
  The food ingested by patients is collected until the day 7 of the stroke so that dieticians can calculate their needs and provide a suitable diet. If this is not sufficient, a reinforced nutrition strategy (meal enrichment) is implemented. On day 5 of the stroke, if energy intake is less than 2/3 of the energy objectives, the strategy is switched to level 2, unless it is possible to increase intake within 48 hours.

Primary outcome measures

• mortality at 30 days after stroke (main criterion) [Time frame: At 30 days of the day of the stroke]

Secondary outcome measures (7)

• Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke [Time frame: At 90 days of the day of the stroke]
• Nutritional status at 30 days defined by BMI, weight change over 30 days and albumin rate, used to classify patients as severely undernourished, moderately undernourished or not undernourished. [Time frame: At 30 days of the day of the stroke]
• Time to occurrence of inhalation pneumonia related to the presence of a feeding tube recorded within 30 days of the day of the stroke [Time frame: Within 30 days of the day of the stroke]
• Time to occurrence of infection related to a catheter dedicated to parenteral nutrition recorded within 30 days of the day of the stroke [Time frame: Within 30 days of the day of the stroke]
• Time to occurrence of death recorded within 30 days of the day of the stroke: [Time frame: Within 30 days of the day of the stroke]
• Hospital stay (in days) with censoring at 3 months after stroke [Time frame: Length of hospitalization (in days), calculated between the stroke 's date (day 0) and the date of discharge from the Neurology Department, assessed up to 90 days after the stroke.]
• Evaluation of the variation in the EuroQol 5D quality of life score (EQ-5D-5L) between the pre-stroke period and 3 months after stroke [Time frame: At 90 days of the day of the stroke]

Eligibility criteria

Inclusion criteria

• Patients ≥ 18 years of age
• With an acute, ischaemic or haemorrhagic outpatient or inpatient stroke
• NIHSS score ≥ 5
• Hospitalised in a neurology department, or Neuro Vascular Unit (NVU), or in a department where beds are dedicated to receiving post-stroke patients
• Stroke less than 2 days old
• Anticipated length of hospital stay in a participating centre ≥ 5 days
• Patient affiliated to or benefiting from a social security scheme
• Patient or close relative having given written consent to participate in the study or patient included under the emergency procedure in the absence of contactable relatives

Exclusion criteria

• Patients treated with nutritional therapy at the time of admission (history of bariatric surgery or gastrectomy, malabsorptive pathologies such as short bowel, extensive intestinal resections, etc.).
• In a palliative situation where life expectancy is < 3 months
• Patient taking part in another study with an impact on mortality or nutrition
• Previous inclusion in the trial
• Pregnant, breast-feeding or parturient woman
• Patient unable to follow the protocol for any reason
• Patient deprived of liberty by judicial or administrative decision
• Patient under compulsory psychiatric care
• Person under legal protection
• Poor understanding of the French language

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

France · 12 centers

• CH Versailles — Chesnay
• CHU Angers — Angers
• CHU Caen — Caen
• CH Cholet — Cholet
• CHD La Roche sur Yon — La Roche-sur-Yon
• CH La Rochelle — La Rochelle
• CH Chartres — Le Coudray
• CHU Rouen — Rouen
• … and 4 more centers

Identifiers

NCT: NCT07065929 · 49RC23_0302 · 2025-A00234-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗