- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02374203
Nutritional Needs and Intake on Clinical Outcomes in Mechanically Ventilated Critically Ill Elderly Patients
31. august 2018 opdateret af: Pi-Hui Hsu, Mackay Memorial Hospital
Clinical Dietitian, Dietetic Service, Mackay Memorial Hospital
The purposes of this study were to investigate the caloric requirement and clinical outcomes in mechanically ventilated critically ill elderly patients and identify those at high nutritional risk who require high protein formula intervention.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The elderly population is rapidly increasing, but studies on calorie requirement in critically ill elderly patients are few, and indirect calorimetry (IC) is not available in every intensive care unit (ICU).
The aim of this study was to compare IC and Harris-Benedict (HB) predictive equation in different BMI (body mass index) groups.
And to investigate whether the nutrition intake from EN (enteral nutrition) and PN (parenteral nutrition) created a better clinical outcome than EN alone in HNR (high nutritional risk) mechanically ventilated critically ill elderly patients.Inclusion criteria were: age ≧65 years old, APACHE Π score ≧15, mechanical ventilation ≧48 hours and on NG tube feeding.
Nutritional risk was screened by mNUTRIC and GNRI.
Indirect calorimetry and HB equation were used to assess energy requirements.
Patients were randomized 1:1 to two tube feeding regimens: general formula and high protein formula (1.5~2.0 gm/kg BW).
Nutritional intake from EN, the type and amount of intravenous nutrition within 7 days, tolerance to feeding, MVD (Mechanical Ventilation Day), newly diagnosed VAP (Ventilator Associated Pneumonia), ICU and hospital LOS (Length of Stay) and date of death were recorded.
We used SAS version 9.4 for statistical analysis.
Statistically significance was set at α=0.05.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
190
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Taipei, Taiwan
- Mackay Memorial Hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- APACHE Π score ≧ 15
- ≧ 65 years
- on mechanical ventilation ≧48 hours
- received EN
Exclusion Criteria:
- Use of total parenteral nutrition
- Fasting >5 days
- Brain death
- Terminal cancer
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: high protein enteral nutrition
supply protein over 1.5 gm/kg body weight
|
supply protein over 1.5 gm/kg body weight
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Determination of the energy requirements in critically ill elderly patients
Tidsramme: first 5 days in the ICU
|
A total of 177 critically ill elderly patients (≧ 65 years old) underwent IC for measured resting energy expenditure (MREE).
Estimated calorie requirement was calculated by the HB equation, using actual body weight (ABW) and ideal body weight (IBW) separately.
Patients were divided into four BMI groups.
One-way ANOVA and Pearson's correlation coefficient were used for statistical analyses.
|
first 5 days in the ICU
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Higher Enteral Nutrition Intake May Reduce Hospital Mortality
Tidsramme: first 28 days in the ICU
|
We included patients ≧ 65 years on mechanical ventilation ≧ 48 hours and received EN.
Nutritional status was evaluated by mNUTRIC score.
We calculated the energy and protein requirements as Harris-Benedict equation ╳ 1.0~1.3 and 1.0~2.0
gm/kg body weight respectively.
Nutrition intake from EN and PN was recorded within 7 days.
ICU and hospital mortalities in HNR elderly patients who could achieve more or less 80% of the prescribed nutrition were compared.
|
first 28 days in the ICU
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pi-Hui Hsu, Mackay Memorial Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Hsu PH, Lee CH, Kuo LK, Kung YC, Chen WJ, Tzeng MS. Higher Energy and Protein Intake from Enteral Nutrition May Reduce Hospital Mortality in Mechanically Ventilated Critically Ill Elderly Patients. International Journal of Gerontology. Available online 26 March 2018. https://doi.org/10.1016/j.ijge.2018.03.001
- Hsu PH, Lee CH, Kuo LK, Kung YC, Chen WJ, Tzeng MS. Determination of the energy requirements in mechanically ventilated critically ill elderly patients in different BMI groups using the Harris-Benedict equation. J Formos Med Assoc. 2018 Apr;117(4):301-307. doi: 10.1016/j.jfma.2017.12.010. Epub 2018 Jan 12.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. december 2014
Primær færdiggørelse (Faktiske)
30. juni 2016
Studieafslutning (Faktiske)
30. juni 2016
Datoer for studieregistrering
Først indsendt
11. december 2014
Først indsendt, der opfyldte QC-kriterier
26. februar 2015
Først opslået (Skøn)
27. februar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. september 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. august 2018
Sidst verificeret
1. august 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 14MMHIS229
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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