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

Renal Resistive Index by Renal Doppler Ultrasound as a Predictor of Acute Kidney Injury and Evaluation of Fluid Administration in Sepsis Patients: Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Acute Kidney Injury; Renal Resistive Index
• Intervention / Treatment: Diagnostic test: Renal resistive index

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 Type: Observational
• Enrollment (Estimated): 45

Contacts and Locations

• Study Contact: Name: Safinaz A Aboelfetoh, MBBCh; Phone Number: 00201148855752; Email: noralamar34@gmail.com

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt, 31527
      • Recruiting
      • Tanta University Hospitals
      • Contact: Safinaz A Aboelfetoh, MBBCh; Phone Number: 00201148855752; Email: noralamar34@gmail.com
      • Sub-Investigator: Ahmed M Hamed, MD
      • Sub-Investigator: Sameh M Sadek, MD
      • Sub-Investigator: Aliaa M Belal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Tanta university surgical intensive care unit (SICU)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
AKI group; 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; 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.; Other Names: Renal Doppler Ultrasound
Non AKI group; Patients who will no develop Acute kidney injury (AKI).	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.; 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

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Safinaz A Aboelfetoh, MBBCh, Anesthesiology, Faculty of Medicine, Tanta University, Egypt.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: August 19, 2023
• First Submitted That Met QC Criteria: August 19, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 19, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Toxemia; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 36264MS189/5/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: The data will be available after the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No