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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426032
• Other study ID #: FMASU M S 299 / 2020
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: July 2021
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis

Intervention

Diagnostic Test:
• Renal Doppler Ultrasound
Measurement of Renal resistive index

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of AKI	incidence of AKI related to Renal resistive index.	1 day at admission
Secondary	APACHE III score	Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 299 worse)	1 day at admission
Secondary	APACHE IV score	Acute Physiology and Chronic Health Evaluation scores. Score range (0 better - 286 worse)	1 day at admission
Secondary	SOFA score	Sequential Organ Failure Assessment (SOFA) score. Score Range (0 better - 24 worse)	1 day at admission