Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study) (RED-AKI)

RED-AKI: Renal Doppler in Acute Kidney Injury. Capability of Intrarenal Venous Flow Doppler (IRVF) to Predict Acute Kidney Injury (AKI) in Critically Ill Patients With Acute Respiratory Distress Syndrome (ARDS)

This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:

• PRIMARY AIM: To describe the capability of IRVF demodulation at diagnosis of ARDS to predict development of AKI within 7 days from the ARDS onset
• SECONDARY AIMS: A)Describe the capability of IRVF demodulation or pattern of IRVF (continuous, pulsatility, biphasic, monophasic) to predict development of AKI within 14 days from the ARDS onset. B) To describe the RD parameters and VexUS in the AKI and no AKI patients over time. C) Describe the impact of invasive mechanical ventilation (IMV) on the intrarenal venous congestion and VexUS., D) Evaluation of effect of CRRT on IRVF pattern, VexUS and parameters. E) Describe the feasibility of renal doppler to assess IRVF in critically ill respiratory patients. F) Evaluate the incidence of AKD and CKD Participants will Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Kidney Injury; ARDS, Human
• Intervention / Treatment: Diagnostic test: ARDS+AKI

• Study Type: Observational
• Enrollment (Estimated): 164

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).

Description

Inclusion Criteria:

• Age > 18 years
• Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria
• Beginning of IMV less than 48 hours or Clinical decision to begin IMV.
• Life expectancy > 24 hours
• Informed consent signed

Exclusion Criteria:

No patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.

• AKI prior to the onset of ARDS
• Chronic respiratory failure due to chronic respiratory diseases
• Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO
• Chronic Heart Failure
• Chronic liver disease
• Major trauma in the past 3 months
• Major surgery in the past 3 months
• Smoking and Alcohol drinking
• BMI ≥ 35
• Patients needing of VV-ECMO and VA-ECMO
• Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)
• Life expectancy <24 hours
• Cardio Circulatory Arrest
• Neoplasm in chemotherapy/radiotherapy
• Do Not Resuscitate or Comfort Measures
• Pregnancy at ICU admission
• Refused Informed Consent by the patient or surrogate decision-maker

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative incidence	Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group	1st april 2024 - 31st of january 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AKI14	) Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern	1st april 2024 - 31st of january 2026
AKIstage	VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage	1st april 2024 - 31st of january 2026
cross talk lung-kidney	invasive mechanical ventilation parameters (PEEP, Pressure of plateau, driving pressure and static compliance of the respiratory system) values and PaCO2 and PaO2/FiO2 values in the demodulated or in any IRVF pattern (continuous, pulsatility, biphasic and monophasic)	1st april 2024 - 31st of january 2026
CRRT	IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT	1st april 2024 - 31st of january 2026
incidence of failed exam	Percentage of exams successfully performed among the total of patients admitted to study	1st april 2024 - 31st of january 2026
CKD progression	Incidence of CKD Incidence of CKD Cumulative Incidence of CKD	1st april 2024 - 31st of january 2026

Collaborators and Investigators

• Sponsor: Policlinico Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Renal Doppler
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury; Respiratory Distress Syndrome
• Other Study ID Numbers: 4302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No