Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorPoliclinico Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ARDS+AKI
Diagnostic testaccording to the clinical practice Reanl doppler and VeXUS score will be performed
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
cumulative incidence
Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group
Time frame
1st april 2024 - 31st of january 2026Secondary outcomes
1
AKI14
) Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern
Time frame
1st april 2024 - 31st of january 20262
AKIstage
VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage
Time frame
1st april 2024 - 31st of january 20263
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)
Time frame
1st april 2024 - 31st of january 20264
CRRT
IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT
Time frame
1st april 2024 - 31st of january 2026Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: