Impact of Early, Personalized Nutritional Management on 1-month Mortality After Acute Stroke
ConditionAcute Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Angers
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Early nutritional management
Dietary supplementThe 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.
Treatment groups
3,084 Participants
are divided into 2 treatment groupsGroup A: Interventional GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
mortality at 30 days after stroke (main criterion)
Recording patient status at 30 days after stroke
Time frame
At 30 days of the day of the strokeSecondary outcomes
1
Proportion of patients with modified Rankin score ≤ 2, 3 months after stroke
Modified Rankin score is evaluated at 3 months after stroke and a percentage of patients with a score \< 2 will be calculated
Time frame
At 90 days of the day of the stroke2
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 stroke3
Time to occurrence of inhalation pneumonia related to the presence of a feeding tube recorded within 30 days of the day of the stroke
Recording of inhalation pneumonia related to the presence of a feeding tube
Time frame
Within 30 days of the day of the stroke4
Time to occurrence of infection related to a catheter dedicated to parenteral nutrition recorded within 30 days of the day of the stroke
Recording of infection related to a catheter dedicated to parenteral nutrition
Time frame
Within 30 days of the day of the strokeSponsors and contacts
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Source ClinicalTrials.gov