Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-24 @ 3:31 PM
NCT ID:
NCT07295392
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Septic patients with AKI: Diagnosis of sepsis is based on combination of variables including Sepsis-3 criteria within 24 hours of ICU admission(suspected or confirmed infection on clinical , lab and imaging evidence , acute increase in SOFA score =\>2 points( or presence of septic shock). The latter is defined by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (\>18 mg/dL) in the absence of hypovolemia (Singer et al 2016).
3. Diagnosis of AKI according to KDIGO-criteria ( increase creatinine by =\>0.3 mg/dl ( =\>26.5 micmol/l ) within 48 hrs or increase cr =\>1.5 × baseline within 7days or urine output \< 0.5 ml / kg / hr for =\> 6hrs)
4. Informed consent obtained and in case patient is unable to sign the consent his next of kin or has power
Exclusion Criteria:
1. Patients diagnosed with ESRD or kidney transplantation
2. Other causes of AKI
3. Pregnancy related causes of AKI
4. Active immunosuppressive therapy (e.g., high-dose steroids, chemotherapy)
5. Patients with background of adult polycystic kidney disease
6. Patients with cardiac failure
7. Patients with solitary kidney because of small renal mass that could affect uromodulin level.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07295392
Study Brief:
Protocol Section:
NCT07295392