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Growth Differentiation Factor 15 in ICU Acquired Muscle Weakness

NCT ID: NCT06713746

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

58 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-09-15

Brief Summary

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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

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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:

1. 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.
2. SOFA score ("Sequential Organ Failure Assessment ") which will be assessed every day.
3. Routine lab investigations other than these in SOFA score as (Urea, Albumin, Hb, TLc, Pt, Ptt, RBG…..ect).
4. Urea:creatinine ratio: Urea and creatinine will be measured daily as a part of SOFA score and urea to creat will be calculated.
5. Plasma Growth differentiation 15 (GDF15) on 1, 4 and 7 days.
6. Ultrasound measurement of rectus femoris cross-sectional area (RFcsa) on 1, 4, 7, 10 and then every 3days according to patients stay in ICU.
7. 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.
8. Length of hospital and ICU stay.
9. Long term out come after 3 months survival, physical activity and return to work

Conditions

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Muscle Weakness

Keywords

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GDF15 Muscle weakness ICU

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ICU patients

muscle weakness

growth differentiation factor 15

Intervention Type 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

Interventions

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growth differentiation factor 15

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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urea to creatinine ratio

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Aya Hamdy Ahmed Nagy

Assistant lecturer of anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Minia university

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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7292021

Identifier Type: -

Identifier Source: org_study_id