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

NCT ID: NCT04426032

Last Updated: 2021-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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).

Conditions

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Acute Kidney Injury Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with RRI between 0.6 and 0.7

Normal renal resistive index

Renal Doppler Ultrasound

Intervention Type DIAGNOSTIC_TEST

Measurement of Renal resistive index

Patients with RRI more than 0.7

High renal resistive index

Renal Doppler Ultrasound

Intervention Type DIAGNOSTIC_TEST

Measurement of Renal resistive index

Interventions

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Renal Doppler Ultrasound

Measurement of Renal resistive index

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Saleh Ahmed Massoud

Lecturer of Anesthesia and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed Saleh Ahmed, MD

Role: STUDY_DIRECTOR

Lecturer of Anesthesia and Intensive Care

Mohammed Saeed Abdelaziz, MD

Role: STUDY_CHAIR

Professor of Anesthesia and Intensive Care

Mona Refaat Hosney, MD

Role: STUDY_DIRECTOR

Assistant Professor of Anesthesia and Intensive Care

Ahmed Abdelsattar Abuelmajd, MBBCH

Role: PRINCIPAL_INVESTIGATOR

Candidate of master degree in general intensive care

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU M S 299 / 2020

Identifier Type: -

Identifier Source: org_study_id

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