- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04533100
The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury.
The Association of Protein-Energy Adequacy With Mortality in Critically Ill Patients With Acute Kidney Injury. A Prospective Observational Single- Centre Study.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Patients with Acute Kidney Injury, AKI are probably more exposed to the risk of malnutrition especially if they undergo Renal Replacement Therapy, RRT. Optimization of nutrients especially energy and protein can ensure a better health outcome for critically ill patients with AKI. Moreover, there is no research on the association of Protein- Energy adequacy with mortality among critically ill patients with AKI in Malaysia. So, the main purpose of this study is to investigate the relationship of Protein-Energy adequacy with mortality among critically ill patients with AKI
Subjects will be recruited upon admission in ICU after fulfilling the inclusion and exclusion criteria. They will be follow up from day 1 until day 14 or until ICU Discharge. Data including Demographic, Clinical, Laboratory, and Nutritional Status will be recorded. On Day 28, the outcome data including Mortality, length of ICU Stay, and Length of Ventilator day will be recorded.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiesteder
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-
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Kuala Lumpur, Malaysia, 59100
- Rekruttering
- University Malaya Medical Centre
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Kontakt:
- MOHD SHAHNAZ HASAN, MBBS
- Telefonnummer: 3869 0379493869
- E-mail: shahnaz@ummc.edu.my
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Patients who are 18 years old and older
- Patients who are admitted to the participating ICU.
- Patients who are mechanically ventilated.
Exclusion Criteria:
- Patients who are less than 18 years old
- End-stage renal disease patients
- Patients undergo kidney transplantation within 3 months before ICU admission
- Pregnant patients
- The patient is moribund with expected death within 24 hour or whom survival to 28 days is unlikely due to uncontrollable comorbidity (cardiac, pulmonary or hepatic end-stage disease; hepatorenal syndrome; poorly controlled cancer; severe post-anoxic encephalopathy and others)
- Prior treatment with RRT within 30 days
- Anticipated alive ICU discharge within 24 hours
- Readmission to the ICU during the same hospitalization episode.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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28-Days Mortality
Tidsramme: 1 day
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Mortality status of subjects on day 28 from recruitment.
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1 day
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Length of ICU Stay
Tidsramme: 1 day
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Duration of ICU Stay from ICU admission until ICU discharge
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1 day
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Length of Ventilator Day
Tidsramme: 1 day
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Duration of ventilator used by subjects from ICU admission until ICU discharge
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1 day
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: MOHD SHAHNAZ HASAN, MBBS, University of Malaya
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MREC ID NO: 2018222-6043
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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