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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT04426032
Collaborator
(none)
150
1
7
21.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Jan 31, 2021
Actual Study Completion Date :
Jan 31, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. incidence of AKI [1 day at admission]

    incidence of AKI related to Renal resistive index.

Secondary Outcome Measures

  1. APACHE III score [1 day at admission]

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

  2. APACHE IV score [1 day at admission]

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

  3. SOFA score [1 day at admission]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
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.

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Saleh Ahmed Massoud, Lecturer of Anesthesia and Intensive Care, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04426032
Other Study ID Numbers:
  • FMASU M S 299 / 2020
First Posted:
Jun 11, 2020
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mohamed Saleh Ahmed Massoud, Lecturer of Anesthesia and Intensive Care, Ain Shams University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021