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Completed

NCT Number: NCT06713746

Growth Differentiation Factor 15 in ICU Acquired Muscle Weakness

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.

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Key information

Conditions

Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Minia university

Minya, Egypt

About this study

After obtaining the approval of research ethical committee of faculty of medicine, Minia university, written informed consent will be obtained from all participants or their legal representatives prior to study inclusion, this prospective cross sectional non randomized observational study will be conducted in intensive care unit Minia university hospital, on conscious non-mechanically ventilated patients with expected ICU stay 7 days or more during the period from January 2022 to December 2022. Based on inclusion and exclusion criteria, patients who met eligibility criteria, the prognosis and outcome of patients developing ICU-AW will be observed.

Parameters will be assessed:

  • Medical history, Age, gender, weight, BMI and APACHE II score ("Acute Physiology and Chronic Health Evaluation II") which is a severity-of-disease classification system one of several ICU scoring systems will be assessed in the day of admission.
  • SOFA score ("Sequential Organ Failure Assessment ") which will be assessed every day.
  • Routine lab investigations other than these in SOFA score as (Urea, Albumin, Hb, TLc, Pt, Ptt, RBG…..ect).
  • Urea:creatinine ratio: Urea and creatinine will be measured daily as a part of SOFA score and urea to creat will be calculated.
  • Plasma Growth differentiation 15 (GDF15) on 1, 4 and 7 days.
  • Ultrasound measurement of rectus femoris cross-sectional area (RFcsa) on 1, 4, 7, 10 and then every 3days according to patients stay in ICU.
  • Muscle Strength Assessment using the Medical Research Council (MRC) score on 1, 4 and 7 days where patients will be divided into an ICU-AW group and a non ICU-AW group according to their MRc-score on the 7th day.
  • Length of hospital and ICU stay.
  • Long term out come after 3 months survival, physical activity and return to work

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

growth differentiation factor 15

Diagnostic Test

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

Other names: urea to creatinine ratio

Primary outcomes

  1. Incidence

    Time frame: 1 year

    to investigate the incidence of intensive care unit acquired muscle weakness

  2. Disease relations

    Time frame: 1 year

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

Secondary outcomes

  1. Daily activity and mortality

    Time frame: 1 year

    to investigate the influence of muscle weakness on daily activity and mortality of ICU acquired patients

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Growth Differentiation Factor 15 Predictive Value, Prognostic Significance and Any Potential Correlation with Urea to Creatinine Ratio in Intensive Care Acquired Weakness

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 3, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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