Sepsis Clinical Trial
Official title:
Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study
NCT number | NCT06009445 |
Other study ID # | 36264MS189/5/23 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2024 |
We aim from this study to investigate the role of renal resistance index (RRI) in evaluation of Acute kidney injury development and fluid administration in sepsis patients considering the change in RRI values over 7 days from admission as a predictor of AKI development
Status | Recruiting |
Enrollment | 45 |
Est. completion date | July 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Age over 21 years - meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock. Exclusion Criteria: - patients during pregnancy. - patients with hepatorenal syndrome. - Poor abdominal echogenicity eg.(morbid obesity ,increase intra abdominal pressure ) - Severe acute or chronic renal insufficiency . - Dialysis dependency. - Renal transplantation. - Known renal artery stenosis. - Mono-kidney, kidney tumor, anatomic kidney abnormalities. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tanta University Hospitals | Tanta | Elgharbia |
Lead Sponsor | Collaborator |
---|---|
Tanta University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prediction of AKI development by renal resistance index (RRI) | AKI was defined according to the Kidney Disease Improving Global Outcome (KDIGO) classification using both creatinine and urine output criteria.
The KDIGO guidelines define AKI as follows Increase in serum creatinine by =0.3 mg/dL (=26.5 micromol/L) within 48 hours, or Increase in serum creatinine to =1.5 times baseline, which is known or presumed to have occurred within the prior seven days, or Urine volume <0.5 mL/kg/hour for six hours |
7 days from admission | |
Secondary | Evaluation of fluid administration | RRI and other hypoperfusion markers after fluid challenge and divided into responder to fluid (Time 1 F) and non responder with noradrenaline administration (Time 1 N) . | 7 days from admission | |
Secondary | Length of ICU stay | Length of ICU stay till discharge will be measured. | 2 months from admission till discharge | |
Secondary | cumulative fluid balance over 7 days | Cumulative fluid balance over 7 days and urine output (intake -output) will be measured. | 7 days from admission | |
Secondary | The incidence of 28 day mortality | The incidence of mortality will be measured at 28 day. | 28 days from admission |
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