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OpenTrials
Completed

NCT Number: NCT04426032

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

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.

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Key information

About this study

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:

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients who have normal renal function on admission.

Exclusion criteria

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

Treatment and study plan

Renal Doppler Ultrasound

Diagnostic Test

Measurement of Renal resistive index

Primary outcomes

  1. incidence of AKI

    Time frame: 1 day at admission

    incidence of AKI related to Renal resistive index.

Secondary outcomes

  1. APACHE III score

    Time frame: 1 day at admission

    Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)

  2. APACHE IV score

    Time frame: 1 day at admission

    Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)

  3. SOFA score

    Time frame: 1 day at admission

    Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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