Nutritional Status, Muscle Wasting and Fraility in Intens... | NCT04709198

Studies
Nutritional Status, Muscle Wasting and Fraility in Intensive Care Patients

NCT04709198

Sponsor

Karadeniz Technical University

Status

Completed

Last Update Posted

Jul 25, 2022Actual

Enrollment

44Actual

Phase

Not provided

Conditions

Critical Illness
Nutritional Disorder

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2020Actual

Primary Completion Date

Jun 20, 2021Actual

Completion Date

Jun 20, 2022Actual

First Submitted Date

Jan 4, 2021

First Submission Date that Met QC Criteria

Jan 12, 2021

First Posted Date

Jan 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 22, 2022

Last Update Posted Date

Jul 25, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Melda Kangalgil, Research Assistant, Karadeniz Technical UniversityPrincipal Investigator

Lead Sponsor

Karadeniz Technical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The risk of muscle wasting is high in the intensive care unit patients during the treatment process and this condition is associated with adverse clinical outcomes. The etiology of muscle wasting is multifactorial and medical nutrition therapy plays a key role in muscle wasting treatment and prevention. The aim of this study is assesing the malnutrition and fraility, anthropometric measurements, and muscle mass by ultrasound at the first admission to the intensive care unit and to determine the nutritional factors affecting clinical outcomes. In addition, it is planned to determine the risk factors affecting the change of anthropometric measurements and muscle wasting in the first week during the intensive care unit.

Detailed Description

A nutrition-focused physical examination is an integral component in the assessment of critically ill patients. Malnutrition, muscle wasting, and frailty are multidimensional clinical conditions in critically ill patients and are associated with adverse outcomes. Although malnutrition, muscle wasting and frailty are linked, the exact relation between them is unsure. As a result of evaluating these conditions together, it is planned to develop new treatment strategies and to improve the clinical results of patients by determining the relationship between medical nutrition therapy.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in muscle cross-sectional area	Rectus femoris muscle cross-sectional area will be evaluated by ultrasound.	Baseline and 7 days
Changes in anthropometric measurements	Triceps skinfold thickness will be measured by caliper.	Baseline and 7 days

Secondary Outcomes

Measure	Description	Time Frame
Duration of mechanical ventilation	Duration of mechanical ventilation in survivors and non survivors	Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
Mortality rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥45 years and ≤80 years, male or female
Expected ICU stay of seven days or longer
Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

Pregnancy or breastfeeding
Neuromuscular conditions (e.g., multiple sclerosis, muscular dystrophy, spinal cord injury, Guillain-Barre syndrome)
Terminal cancer
Dialysis dependent chronic renal failure
Intoxication
Burn injury
A cognitive impairment prior to the acute illness that is associated with admission to ICU that would impair capacity to follow verbal instructions
Concurrent enrolment in a nutrition-related interventional study at the time of screening

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Critically ill patients aged between 45-80 years of both sexes

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ahmet Oguzhan Kucuk, MD	Karadeniz Technical University	Principal Investigator
Hulya Ulusoy, Professor	Karadeniz Technical University	Principal Investigator
Ayse Ozfer Ozcelik, Professor	Ankara University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karadeniz Technical University Faculty of Health Sciences		Trabzon	Eyalet/Yerleşke	61080	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D009748	Nutrition Disorders

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided