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

NCT04426032 | Completed

• 1 other identifier: FMASU M S 299 / 2020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Sepsis

Keywords

Acute Kidney Injury; Sepsis

Outcome Measures

Primary Outcomes (1)

• incidence of AKI

  incidence of AKI related to Renal resistive index.

  1 day at admission

Secondary Outcomes (3)

• APACHE III score

  1 day at admission

• APACHE IV score

  1 day at admission

• SOFA score

  1 day at admission

Study Arms (2)

Patients with RRI between 0.6 and 0.7

Normal renal resistive index

Diagnostic Test: Renal Doppler Ultrasound

Patients with RRI more than 0.7

High renal resistive index

Diagnostic Test: Renal Doppler Ultrasound

Interventions

Renal Doppler Ultrasound DIAGNOSTIC_TEST

Measurement of Renal resistive index

Patients with RRI between 0.6 and 0.7; Patients with RRI more than 0.7

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients with obstructive renal failure, renal artery stenosis were excluded from this study.
• Patients on chemotherapy and/or radiotherapy.
• Pregnancy.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohamed Saleh Ahmed, MD

  Lecturer of Anesthesia and Intensive Care

  STUDY DIRECTOR

• Mohammed Saeed Abdelaziz, MD

  Professor of Anesthesia and Intensive Care

  STUDY CHAIR

• Mona Refaat Hosney, MD

  Assistant Professor of Anesthesia and Intensive Care

  STUDY DIRECTOR

• Ahmed Abdelsattar Abuelmajd, MBBCH

  Candidate of master degree in general intensive care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

EG (1)