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

Recruiting

• Conditions: Acute Kidney Injury; Renal Resistive Index; Sepsis
• Interventions: Diagnostic Test: Renal resistive index

• Registration Number: NCT06009445
• Lead Sponsor: Tanta University

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

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-19
• Study First Submitted QC: 2023-08-19
• Last Update Submitted: 2023-08-19
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-24
• Primary Completion: 2024-07-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non AKI group	Renal resistive index	Patients who will no develop Acute kidney injury (AKI).
AKI group	Renal resistive index	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

Primary Outcome Measures

Name	Time	Method
Prediction of AKI development by renal resistance index (RRI)	7 days from admission	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

Secondary Outcome Measures

Name	Time	Method
The incidence of 28 day mortality	28 days from admission	The incidence of mortality will be measured at 28 day.
Length of ICU stay	2 months from admission till discharge	Length of ICU stay till discharge will be measured.
cumulative fluid balance over 7 days	7 days from admission	Cumulative fluid balance over 7 days and urine output (intake -output) will be measured.
Evaluation of fluid administration	7 days from admission	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) .

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Elgharbia, Egypt