Renal Resistive Index as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
Acute kidney injury (AKI) is one of the most common problems in critically ill patients in the clinic. AKI can be caused by various factors, such as hypovolemia, shock, major surgery, trauma, and heart failure, of which sepsis is the most common

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

Conditions
-----------------
Renal Resistive Index, Acute Kidney Injury, Sepsis

Intervention / Treatment
-----------------
* Diagnostic Test: Renal resistive index


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AKI group<br>Acute kidney injury (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 | Diagnostic Test: Renal resistive index<br>* The calculation formula for Renal resistive index (RRI) as follows : (systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity . will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney. The median value of each section will be used and the 3 median values of each kidney will be averaged.<br>* Other names: Renal Doppler Ultrasound;|
| Non AKI group<br>Patients who will no develop Acute kidney injury (AKI). | Diagnostic Test: Renal resistive index<br>* The calculation formula for Renal resistive index (RRI) as follows : (systolic peak flow velocity _ diastolic minimum flow velocity )/systolic peak flow velocity . will be measured with ultrasound-Doppler using an abdominal curvilinear probe ultrasonography by two independent, trained sonographers (who will not be involved in patient care. After visualizing the kidney in ultrasound mode and checking for renal abnormalities, an arcuate or interlobar artery will be localized and three successive doppler measurements at different positions in the kidney (high, middle and low) will be performed, 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney. The median value of each section will be used and the 3 median values of each kidney will be averaged.<br>* Other names: Renal Doppler Ultrasound;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Length of ICU stay | Length of ICU stay till discharge will be measured. | 2 months from admission till discharge | 
| cumulative fluid balance over 7 days | Cumulative fluid balance over 7 days and urine output (intake -output) will be measured. | 7 days from admission | 
| The incidence of 28 day mortality | The incidence of mortality will be measured at 28 day. | 28 days from admission |