Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU

Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.

Acute kidney injury (AKI) Diagnosis is based on rising creatinine. Intrarenal vasoconstriction occurs earlier and measuring flow resistance in the renal circulation (Renal Resistive Index (RRI)) could become part of vital organ function assessment using Doppler ultrasound.

The aim of this study is to predict AKI in septic patients in ICU by measuring RRI on admission by comparing two groups of patients, first group with RRI of normal value (0.6-0.7) and the other group with high RRI more than 0.7 and both with normal renal function on admission.

Study Overview

• Status: Completed
• Conditions: Sepsis; Acute Kidney Injury
• Intervention / Treatment: Diagnostic test: Renal Doppler Ultrasound

Detailed Description

Patients who have criteria of sepsis, with normal renal function on admission will undergo Renal Doppler Ultrasound examination to measure Renal resistive index.

Patients will be divided into 2 groups:

1. Group (A) patients with renal resistive index between 0.6 and 0.7 (normal RRI).
2. Group (B) patients with renal resistive index more than 0.7 (high RRI).

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on admission.

Description

Inclusion Criteria:

1. Patients who have criteria of sepsis on admission which include two or more of SIRS which include: (Temperature >38°C or <36°C, Heart rate >90/min, Respiratory rate >20/min or PaCO2 <32mmHg (4.3kPa) and White blood cell count >12000/mm3 or <4000/mm3 or >10% immature bands.) in addition to suspected or confirmed infection.
2. Patients who have normal renal function on admission.

Exclusion Criteria:

1. Currently recovering from an AKI at the time of inclusion and Renal impairment on admission.
2. Patients with obstructive renal failure, renal artery stenosis were excluded from this study.
3. Patients on chemotherapy and/or radiotherapy.
4. Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with RRI between 0.6 and 0.7; Normal renal resistive index	Diagnostic test: Renal Doppler Ultrasound; Measurement of Renal resistive index
Patients with RRI more than 0.7; High renal resistive index	Diagnostic test: Renal Doppler Ultrasound; Measurement of Renal resistive index

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of AKI	incidence of AKI related to Renal resistive index.	1 day at admission

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
APACHE III score	Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)	1 day at admission
APACHE IV score	Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)	1 day at admission
SOFA score	Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)	1 day at admission

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Director: Mohamed Saleh Ahmed, MD, Lecturer of Anesthesia and Intensive Care; Study Chair: Mohammed Saeed Abdelaziz, MD, Professor of Anesthesia and Intensive Care; Study Director: Mona Refaat Hosney, MD, Assistant Professor of Anesthesia and Intensive Care; Principal Investigator: Ahmed Abdelsattar Abuelmajd, MBBCH, Candidate of master degree in general intensive care

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Sepsis; Acute Kidney Injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: FMASU M S 299 / 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

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