Muscle WeaknessNCT06713746
Growth Differentiation Factor 15 in ICU Acquired Muscle Weakness
An observational study of Muscle Weakness, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- growth differentiation factor 15
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- age more than 18 conscious patients patients with expected ICU stay more than 7 days
Who cannot join
- unconscious patients spinal cord injury limb fracture or amputations history of cognitive dysfunction severe oedema end stage kidney disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Growth Differentiation Factor 15 Predictive Value, Prognostic Significance and Any Potential Correlation With Urea to Creatinine Ratio in Intensive Care Acquired 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.
Read the detailed description
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. 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
- Conditions
- Muscle Weakness
- Being tested
- growth differentiation factor 15
- Keywords
- GDF15 Muscle weakness ICU
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
growth differentiation factor 15Diagnostic test
Also called urea to creatinine ratio
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
| Study group | Role | What they receive |
|---|---|---|
| ICU patients | muscle weakness Receives: Diagnostic Test: growth differentiation factor 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
to investigate the incidence of intensive care unit acquired muscle weakness
Measured: 1 year
Disease relations
to examine if there is any correlation between GDF15 level or urea-creatinine ratio and ICU acquired muscle weakness
Measured: 1 year
Secondary outcomes (1)
Daily activity and mortality
to investigate the influence of muscle weakness on daily activity and mortality of ICU acquired patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Oct 2023
- Primary completion1 Oct 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Hamdy Ahmed Nagy, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713746
- Sponsor's protocol ID
- 7292021
- Status last verified
- Sep 2026
- First submitted
- 29 Nov 2021
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Differentiation Factor 15 Predictive Value, Prognostic Significance and Any Potential Correlation With Urea to Creatinine Ratio in Intensive Care Acquired Weakness
- ClinicalTrials.gov ID
- NCT06713746
- Acronym / sponsor ID
- 7292021
- Conditions
- Muscle Weakness
- Keywords
- GDF15 Muscle weakness ICU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. 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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients | – | Diagnostic Test: growth differentiation factor 15muscle weakness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- age more than 18 conscious patients patients with expected ICU stay more than 7 days
Key exclusion criteria (1 listed)
- unconscious patients spinal cord injury limb fracture or amputations history of cognitive dysfunction severe oedema end stage kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| growth differentiation factor 15Also: urea to creatinine ratiorowth 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 | Diagnostic test | ICU patients |
Primary outcome
Incidence
Time frame: 1 year
to investigate the incidence of intensive care unit acquired muscle weakness
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
1 secondary outcome
Daily activity and mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle Weakness, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026; AzTrials last refreshed its copy on 6 Nov 2026.