NCT06713746

Brief Summary

Intensive care unit -acquired weakness (ICU- AW) is a common consequence linked to a worse outcome as evidenced by prolonged mechanical ventilation, longer ICU stays, greater mortality rates and a lower quality of life for survivors, so early detection and treatment of ICU-AW are critical. However, there is no "gold standard" currently available for assessing and diagnosing ICU-AW. It's crucial to develop diagnostic methods that enable for early detection and risk stratification in all critically ill patients, such as: GDF-15 (growth differentiation factor-15) is thought to be a mediator of muscle atrophy because its level increases in the muscular atrophy As a result, measuring GDF-15 seems promise for diagnosing muscle atrophy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

November 29, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

September 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
Last Updated

December 9, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

November 29, 2021

Last Update Submit

December 4, 2024

Conditions

Keywords

GDF15 Muscle weakness ICU

Outcome Measures

Primary Outcomes (2)

  • Incidence

    to investigate the incidence of intensive care unit acquired muscle weakness

    1 year

  • Disease relations

    to examine if there is any correlation between GDF15 level or urea-creatinine ratio and ICU acquired muscle weakness

    1 year

Secondary Outcomes (1)

  • Daily activity and mortality

    1 year

Study Arms (1)

ICU patients

muscle weakness

Diagnostic Test: growth differentiation factor 15

Interventions

rowth differentiation factor-15 (GDF-15) is a novel cytokine secreted by a variety of cells like macrophages, adipocytes, normally expressed in high amounts by placenta

Also known as: urea to creatinine ratio
ICU patients

Eligibility Criteria

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

patients older than 18, conscious non mechanically ventilated patients and those with expected ICU stay more than 7 days during the period from September 2023 to September 2024

You may qualify if:

  • age more than 18 conscious patients patients with expected ICU stay more than 7 days

You may not qualify if:

  • \- unconscious patients spinal cord injury limb fracture or amputations history of cognitive dysfunction severe oedema end stage kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia university

Minya, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of anesthesia and intensive care department

Study Record Dates

First Submitted

November 29, 2021

First Posted

December 3, 2024

Study Start

September 10, 2023

Primary Completion

September 10, 2024

Study Completion

September 15, 2024

Last Updated

December 9, 2024

Record last verified: 2024-11

Locations