A Trial to Assess the Effect of High Nitrogen Intake in Critically Ill Patients
23. maj 2020 opdateret af: Ming Zhong, Shanghai Zhongshan Hospital
The Efficacy and Safety of High Nitrogen Intake in Critically Ill Patients: a Randomized and Controlled Trial
The patients with sepsis are in high risk of malnutrition, which could contribute to infection, difficulty in weaning from ventilators.
The investigators speculate whether nutrition therapy with high nitrogen could attenuate the malnutrition status and improve the outcome in these sepsis patients.
In this prospective Randomized Controlled Trial, the investigators aim to compare high nitrogen intake with conventional nitrogen supply which were recommended in guidelines.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
89
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200032
- Division of Critical Care Medicine: Zhongshan Hospital
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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
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- need mechanical ventilation for more than 2 days
- mean blood pressure more than 60mmHg
- predicted ICU stay more than 7 days
- tolerance of parenteral or enteral nutrition
Exclusion Criteria:
- irreversible status of primary disease
- any history of malnutrition before enrollment
- history of steroid cortisol administration
- severe liver dysfunction (Child-Pugh Score C)
- pregnancy
- refuse to enrollment
- re-admission to ICU and has been enrolled during former admission to ICU
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: High Nitrogen
In this arm, daily nitrogen supply is as much as 2.5-3.0 g per kilogram (lean mass weight)
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Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
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Aktiv komparator: conventional nitrogen
In this arm, daily nitrogen supply is 1.2-1.5g
per kilogram (lean mass weight) as recommended by ESPEN guideline
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Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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alle forårsager dødelighed
Tidsramme: 28 dage
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28 dage
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alle forårsager dødelighed
Tidsramme: 90 dage
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90 dage
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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duration on ventilators
Tidsramme: patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
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patients enrolled will be followed for the duration of mechanical ventilation, an expcected average of 4 weeks
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ICU stay
Tidsramme: patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
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patients enrolled will be followed for length of ICU stay, an expected average of 6 weeks
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infection incidence rate
Tidsramme: 28 days
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Details of infection includes pneumonia, catheter-related blood stream infection, urinary tract infect, et al.
Diagnosis of infection accords to symptoms, lab tests, imaging measurements and bacterial cultures.
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28 days
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Liver function and renal function
Tidsramme: on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment
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Liver function is assessed through serum bilirubin and liver enzyme, renal function is assessed through serum urea nitrogen and creatinine.
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on 1st. day, 3rd. day, 7th. day, 14th. day, 21st. day, 28th. day after enrollment
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diameter of midpoint of musculus rectus femoris
Tidsramme: on 28th. day or endpoint of the trial
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diameter of the muscle is measured with percutaneous ultrasound
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on 28th. day or endpoint of the trial
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serum concentration of albumin, pre albumin, retinaldehyde binding protein, transferrin
Tidsramme: on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
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on 7th. day , 14th. day, 21st. day, 28th. day after enrollment
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change of body composition
Tidsramme: on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
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on 7th.day, 14th.day, 21st.dat, 28th.day after enrollment
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. marts 2015
Primær færdiggørelse (Faktiske)
1. januar 2020
Studieafslutning (Faktiske)
1. maj 2020
Datoer for studieregistrering
Først indsendt
30. marts 2014
Først indsendt, der opfyldte QC-kriterier
3. april 2014
Først opslået (Skøn)
8. april 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. maj 2020
Sidst verificeret
1. maj 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HiNiCi
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Kliniske forsøg med nitrogen supply
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PossibleNational Institutes of Health (NIH); Brigham and Women's HospitalUkendtSpædbørnsdødelighed | Dødelighed under 2 årNepal