NCT06117462

Brief Summary

In the study ,investigator aim to evaluate the frailty syndrome in critically ill patients, in both young and old populations,to determine its imapct on outcome, and impact of ICU in fraility

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

September 28, 2023

Last Update Submit

November 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • detect the impact of frailty on outcome(hospital stay and mortality).In Critical care units patients.

    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

Study Arms (2)

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.

Other: 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.

Other: Assesment of CFS

Interventions

Assesment of CFS

Age above 60 elderyage between 18:60 young

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • All ICU patients \>18 years

You may not qualify if:

  • Age \<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 30596641BACKGROUND
  • 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.

    PMID: 16791666BACKGROUND
  • 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.

    PMID: 31784798BACKGROUND
  • 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.

    PMID: 35119497BACKGROUND
  • 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.

    PMID: 28676896BACKGROUND

Central Study Contacts

Doaa Mostafa Ibrahim

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator , Residant doctor ,critical care unit ,internal medicine department

Study Record Dates

First Submitted

September 28, 2023

First Posted

November 7, 2023

Study Start

December 1, 2023

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11