Clinical trial NCT04426032: Predictive Value of Doppler RSI for Prediction of AKI in Septic Patients in ICU
Official title: Predictive Value of Doppler Renal Resistive Index for Prediction of Acute Kidney Injury in Septic Patients in Intensive Care Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Sepsis
Keywords: Acute Kidney Injury
Sepsis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sex admitted to ICU, with criteria of sepsis, and normal renal function on admission.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: incidence of AKI
timeFrame: 1 day at admission
Secondary outcomes:
measure: APACHE III score
timeFrame: 1 day at admission
measure: APACHE IV score
timeFrame: 1 day at admission
measure: SOFA score
timeFrame: 1 day at admission
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Lecturer of Anesthesia and Intensive Care
name: Mohamed Saleh Ahmed, MD
role: STUDY_DIRECTOR
affiliation: Professor of Anesthesia and Intensive Care
name: Mohammed Saeed Abdelaziz, MD
role: STUDY_CHAIR
affiliation: Assistant Professor of Anesthesia and Intensive Care
name: Mona Refaat Hosney, MD
role: STUDY_DIRECTOR
affiliation: Candidate of master degree in general intensive care
name: Ahmed Abdelsattar Abuelmajd, MBBCH
role: PRINCIPAL_INVESTIGATOR
References: