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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06009445
• Other study ID #: 36264MS189/5/23
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Tanta University
• Contact: Safinaz A Aboelfetoh, MBBCh
• Phone: 00201148855752
• Email: noralamar34[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Renal Resistive Index
• Sepsis
• Toxemia
• Wounds and Injuries

Intervention

Diagnostic Test:
• Renal resistive index
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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

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