NCT05567549

Brief Summary

The goal of this observational study is to evaluate in elderly patients for the frequency of sarcopenia and its relationship with mortality in a university hospital. The main questions it aims to answer are;

  1. 1.What is the frequency of sarcopenia in elderly patients at emergency department?
  2. 2.Is sarcopenia associated with mortality in an elderly patient admitted to the emergency department?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

October 3, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

October 10, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

October 5, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 3, 2022

Last Update Submit

October 3, 2022

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

  • Mortality

    0-28 days

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 65 years of age, who can walk independently, who do not have lower extremity fractures or neuromuscular disease, will constitute the study population. The mortality rate over the age of 65 was found to be 11%. Considering that the mortality rate with sarcopenia was 28%, it was found that 63 patients were required for the effect of sarcopenia on mortality with a 95% confidence interval and 0.5% margin of error. Since the incidence of sarcopenia in the emergency department was 33%, 200 patients were planned to be included in the study.

You may qualify if:

  • Above the age of 65 admitted to the emergency department
  • Able to walk without support
  • No lower extremity fracture
  • No disease with neuromuscular involvement

You may not qualify if:

  • In the presence of a cerebrovascular event
  • Those in need of critical intervention when applying to the emergency department
  • Unconscious patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Turkey (Türkiye)

Location

Related Publications (5)

  • Morley JE. Sarcopenia: diagnosis and treatment. J Nutr Health Aging. 2008 Aug-Sep;12(7):452-6. doi: 10.1007/BF02982705. No abstract available.

    PMID: 18615226BACKGROUND

  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND

  • Roberts S, Collins P, Rattray M. Identifying and Managing Malnutrition, Frailty and Sarcopenia in the Community: A Narrative Review. Nutrients. 2021 Jul 5;13(7):2316. doi: 10.3390/nu13072316.

    PMID: 34371823BACKGROUND

  • Hung SK, Kou HW, Hsu KH, Wu CT, Lee CW, Leonard Goh ZN, Seak CK, Chen-Yeen Seak J, Liu YT, Seak CJ; SPOT investigators. Sarcopenia is a useful risk stratification tool to prognosticate splenic abscess patients in the emergency department. J Formos Med Assoc. 2021 Mar;120(3):997-1004. doi: 10.1016/j.jfma.2020.08.039. Epub 2020 Sep 9.

    PMID: 32917483BACKGROUND

  • McQuade C, Kavanagh DO, O'Brien C, Hunter K, Nally D, Hickie C, Ward E, Torreggiani WC. CT-determined sarcopenia as a predictor of post-operative outcomes in patients undergoing an emergency laparotomy. Clin Imaging. 2021 Nov;79:273-277. doi: 10.1016/j.clinimag.2021.05.015. Epub 2021 May 18.

    PMID: 34171595BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 5, 2022

Study Start

October 10, 2022

Primary Completion

July 10, 2023

Study Completion

September 10, 2023

Last Updated

October 5, 2022

Record last verified: 2022-10

Locations

TU(1)