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

NCT06009445 | Unknown

• 1 other identifier: 36264MS189/5/23
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Resistive Index; Acute Kidney Injury; Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of fluid administration

  7 days from admission

• Length of ICU stay

  2 months from admission till discharge

• cumulative fluid balance over 7 days

  7 days from admission

• The incidence of 28 day mortality

  28 days from admission

Study Arms (2)

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

Non AKI group

Patients who will no develop Acute kidney injury (AKI).

Diagnostic Test: Renal resistive index

Interventions

Renal resistive index DIAGNOSTIC_TEST

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.

Also known as: Renal Doppler Ultrasound

AKI group; Non AKI group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age over 21 years
• meet Sepsis 3 criteria (potential source of infection , host response and organ dysfunction) but not in septic shock.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Elgharbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Safinaz A Aboelfetoh, MBBCh

  Anesthesiology, Faculty of Medicine, Tanta University, Egypt.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Safinaz A Aboelfetoh, MBBCh

CONTACT

00201148855752; noralamar34@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 19, 2023
• First Posted: August 24, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available after the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)