- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06117462
Frailty in Critical Care Unit's Patients
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Doaa Mostafa Ibrahim
- Phone Number: 01141896238
- Email: doaamostafa299@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
The initial clinical data will include socio-demographic data, comorbidities (diabetes mellitus (DM), hypertension (HTN), ischemic heart disease (IHD), chronic kidney disease (CKD), chronic liver disease, chronic pulmonary disease, or malignancy), in addition to the acute insult causing the admission.
Candidates will be divided into two groups, group (A): >60 years, and group (B) aged between 18-60 years, both groups will be assessed using the Clinical Frailty Scale (CFS) giving patients who are very fit score one and those who are terminally ill score nine.
Description
Inclusion Criteria:
- All ICU patients >18 years
Exclusion Criteria:
- Age <18 years
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Age above 60 eldery
group will be assessed using the Clinical Frailty Scale (CFS) giving patients who are very fit score one and those who are terminally ill score nine.
|
Assesment of CFS
|
|
age between 18:60 young
group will be assessed using the Clinical Frailty Scale (CFS) giving patients who are very fit score one and those who are terminally ill score nine.
|
Assesment of CFS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
detect the impact of frailty on outcome(hospital stay and mortality).In Critical care units patients.
Time Frame: the CFS before hospital admission and at day up to 1 week of discharge from CCU, CFS mininum 1 ,maximum 9 patient's basal score[ pre intervention] on day of admission and the outcome score at day of discharge [5day],score 1better than higher
|
evaluate the frailty syndrome in critical care unit ,in young and old populations.CFS will report patient's basal score[ pre intervention] on day of admission and the outcome score at day of discharge [5day],score 1better than higher
|
the CFS before hospital admission and at day up to 1 week of discharge from CCU, CFS mininum 1 ,maximum 9 patient's basal score[ pre intervention] on day of admission and the outcome score at day of discharge [5day],score 1better than higher
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Muscedere J, Waters B, Varambally A, Bagshaw SM, Boyd JG, Maslove D, Sibley S, Rockwood K. The impact of frailty on intensive care unit outcomes: a systematic review and meta-analysis. Intensive Care Med. 2017 Aug;43(8):1105-1122. doi: 10.1007/s00134-017-4867-0. Epub 2017 Jul 4.
- Liu Z, Kuo PL, Horvath S, Crimmins E, Ferrucci L, Levine M. A new aging measure captures morbidity and mortality risk across diverse subpopulations from NHANES IV: A cohort study. PLoS Med. 2018 Dec 31;15(12):e1002718. doi: 10.1371/journal.pmed.1002718. eCollection 2018 Dec. Erratum In: PLoS Med. 2019 Feb 25;16(2):e1002760.
- de Rooij SE, Govers A, Korevaar JC, Abu-Hanna A, Levi M, de Jonge E. Short-term and long-term mortality in very elderly patients admitted to an intensive care unit. Intensive Care Med. 2006 Jul;32(7):1039-44. doi: 10.1007/s00134-006-0171-0. Epub 2006 May 9.
- Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjolner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29.
- Darvall JN, Bellomo R, Bailey M, Young PJ, Rockwood K, Pilcher D. Impact of frailty on persistent critical illness: a population-based cohort study. Intensive Care Med. 2022 Mar;48(3):343-351. doi: 10.1007/s00134-022-06617-0. Epub 2022 Feb 4.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fraility in CCU
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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