- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03048487
Protein Consumption in Critically Ill Patients
2. november 2018 opdateret af: Société des Produits Nestlé (SPN)
Protein Consumption in Critically Ill Patients: A Retrospective Study
A retrospective study of protein intake and needs as well as outcomes in critically ill adult patients.
Data will be collected for up to 7 days of ICU stay.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
This retrospective study of critically ill adults receiving enteral nutrition will assess the ability to meet estimated protein and energy needs via enteral nutrition.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
2000
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
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Scranton, Pennsylvania, Forenede Stater, 18510
- Geisinger Community Medical Center, Scranton, PA
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Wilkes-Barre, Pennsylvania, Forenede Stater, 18711
- Geisinger Wyoming Valley Medical Center
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
The study population will include all patients with an ICU admission receiving enteral nutrition in a 36-month period.
Beskrivelse
Inclusion Criteria:
- Adult patients (age ≥18 years)
- Admitted to the ICU
- Administered at least one dose of enteral formula
Exclusion Criteria:
- Receiving exclusive oral or exclusive parenteral nutrition
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Daily protein intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Enteral formula utilized (Standard, High protein, Very high protein)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Daily caloric intake (from Parenteral Nutrition, Enteral Nutrition, oral diet, and medication)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Estimated caloric needs (Kcal/day)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Method for estimating caloric needs (descriptive name of scale) calorie needs met.
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Percentage of daily caloric needs met (%) calorie needs met.
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Estimated protein needs (grams protein/day)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Method for estimating protein needs (descriptive name of scale)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Percentage of daily protein needs met (%)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Blood Urea Nitrogen)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Creatinine)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Aspartate aminotransferase)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Alanine transaminase)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Glucose)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Laboratory values (Ammonia)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Gastrointestinal side effects observed in enterally fed patients in the ICU
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Insulin use
Tidsramme: Daily dose up to 7 days of ICU stay
|
Daily dose up to 7 days of ICU stay
|
|
|
Health Outcomes (Renal failure, Seizures, Encephalopathy, Hyperglycemia, Hypoglycemia)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Utilization of renal replacement therapy (Yes/No)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Utilization of medications to manage hepatic encephalopathy (lactulose) (Yes/No)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Neurocognitive status (Glasgow Coma Scale)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
Presence of delirium (Yes/No)
Tidsramme: Daily up to 7 days of ICU stay
|
Daily up to 7 days of ICU stay
|
|
|
ICU Length of Stay
Tidsramme: Up to 90 Days
|
Up to 90 Days
|
|
|
Hospital Length of Stay
Tidsramme: Up to 90 Days
|
Up to 90 Days
|
|
|
Ventilator days
Tidsramme: Up to 90 Days
|
Up to 90 Days
|
|
|
Antibiotic therapy days
Tidsramme: Up to 90 Days
|
Up to 90 Days
|
|
|
30 day readmission
Tidsramme: Incidence up to 30 days post discharge
|
Incidence up to 30 days post discharge
|
|
|
Death during hospitalization (Yes/No)
Tidsramme: Through study completion, assessed an estimated 36 months
|
Through study completion, assessed an estimated 36 months
|
|
|
Destination for discharge (home, another acute care hospital, Long Term Acute Care, rehabilitation center, nursing home)
Tidsramme: Through study completion, assessed an estimated 36 months
|
Destination of Discharge will be assessed via chart review.
|
Through study completion, assessed an estimated 36 months
|
|
Discharge against medical advice (Yes/No)
Tidsramme: Through study completion, assessed an estimated 36 months
|
Through study completion, assessed an estimated 36 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Joseph Layon, MD, FACP, Geisinger Clinic
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
1. september 2016
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. september 2018
Datoer for studieregistrering
Først indsendt
4. oktober 2016
Først indsendt, der opfyldte QC-kriterier
7. februar 2017
Først opslået (Skøn)
9. februar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
2. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16.11.CLI
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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