- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT06713746
Facteur de différenciation de croissance 15 dans la faiblesse musculaire acquise en soins intensifs
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
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Minya, Egypte
- Minia university
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
ICU patients
muscle weakness |
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
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence
Délai: 1 year
|
to investigate the incidence of intensive care unit acquired muscle weakness |
1 year
|
|
Disease relations
Délai: 1 year
|
to examine if there is any correlation between GDF15 level or urea-creatinine ratio and ICU acquired muscle weakness |
1 year
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Daily activity and mortality
Délai: 1 year
|
to investigate the influence of muscle weakness on daily activity and mortality of ICU acquired patients |
1 year
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 7292021
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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