Exploring metabolic changes in kidney cells after severe trauma
Metabolic Reprogramming in Renal Tubular Cells in Acute Kidney Injury Following Severe Trauma
Assistance Publique - Hôpitaux de Paris · NCT06167512
This study is trying to understand how severe trauma affects kidney cells in adults by looking at blood and urine samples from patients and healthy volunteers to see what changes happen and how they relate to organ function.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 2 sites (Le Kremlin-Bicêtre and 1 other locations) |
| Trial ID | NCT06167512 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the metabolic and hormonal pathways involved in acute kidney injury (AKI) and acute respiratory distress syndrome (ARDS) following severe trauma. It will include 60 adult patients with severe trauma and 20 healthy volunteers as a reference group. Blood and urine samples will be collected at various time points after ICU admission to analyze metabolic changes and their association with organ function impairment. The study seeks to identify the pathophysiological mechanisms leading to multi-organ failure, which could inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have sustained severe trauma with an Injury Severity Score of 9 or higher.
Not a fit: Patients with chronic renal failure on dialysis, chronic respiratory disease, or systemic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and prevention of organ failure in trauma patients, potentially reducing morbidity and mortality.
How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding metabolic changes associated with trauma and organ failure.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Trauma patients : * Adult patients (age ≥ 18 years) * Patient admitted for suspected severe trauma (1 Vittel criteria) * Injury Severity Score ≥ 9 * Health insurance * Written consent obtained from the patient or trusted support person / family member / close friend, or inclusion in an emergency situation and written consent obtained from the patient (trusted support person / family member / close friend if necessary) as soon as possible (article L1122-1-2 of the CSP). Healthy volunteers : * Adult patients (≥ 18 years) * Affiliated with health insurance * Written informed consent́ * Patient respecting matching Exclusion Criteria: Trauma patients : * Pregnant patient * Minor patient * Adult under guardianship, curatorship or safeguard of justice * Patient under Aide Médicale d'État * Chronic renal failure on dialysis * Chronic respiratory disease * Patient with chronic cardiac insufficiency * Systemic inflammatory disease Healthy volunteers : * Pregnant patient * Minor patient * Adult under guardianship, curatorship or safeguard of justice * Patient under Aide Médicale d'État * Patient with chronic renal failure on dialysis * Chronic respiratory disease * Patient with chronic cardiac insufficiency * Systemic inflammatory disease
Where this trial is running
Le Kremlin-Bicêtre and 1 other locations
- Bicetre hospital — Le Kremlin-Bicêtre, France (RECRUITING)
- Bicetre hospital — Le Kremlin-Bicêtre, France (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multi-organ Failure After Severe Trauma, Severe trauma, hemorrhagic shock, Acute kidney Injury, Acute respiratory distress syndrome, Multi-organ failure