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

Completed

• Conditions: Acute Kidney Injury; Sepsis
• Interventions: Diagnostic Test: Renal Doppler Ultrasound

• Registration Number: NCT04426032
• Lead Sponsor: Ain Shams University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-07-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with RRI between 0.6 and 0.7	Renal Doppler Ultrasound	Normal renal resistive index
Patients with RRI more than 0.7	Renal Doppler Ultrasound	High renal resistive index

Primary Outcome Measures

Name	Time	Method
incidence of AKI	1 day at admission	incidence of AKI related to Renal resistive index.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt