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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06009445
Collaborator
(none)
45
1
12
3.7

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
45 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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) .

    2. Length of ICU stay [2 months from admission till discharge]

      Length of ICU stay till discharge will be measured.

    3. cumulative fluid balance over 7 days [7 days from admission]

      Cumulative fluid balance over 7 days and urine output (intake -output) will be measured.

    4. The incidence of 28 day mortality [28 days from admission]

      The incidence of mortality will be measured at 28 day.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanta University Hospitals Tanta Elgharbia Egypt 31527

    Sponsors and Collaborators

    • Tanta University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Safinaz Abdelkhalek Aboelfetoh, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt., Tanta University
    ClinicalTrials.gov Identifier:
    NCT06009445
    Other Study ID Numbers:
    • 36264MS189/5/23
    First Posted:
    Aug 24, 2023
    Last Update Posted:
    Aug 24, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2023