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

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)

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06302192
Acronym
RED-AKI
Enrollment
164
Registered
2024-03-08
Start date
2024-04-01
Completion date
2026-06-30
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, ARDS, Human

Keywords

Renal Doppler

Brief summary

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

Interventions

DIAGNOSTIC_TESTARDS+AKI

according to the clinical practice Reanl doppler and VeXUS score will be performed

Sponsors

Policlinico Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cumulative incidence1st april 2024 - 31st of january 2026Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group

Secondary

MeasureTime frameDescription
AKIstage1st april 2024 - 31st of january 2026VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage
cross talk lung-kidney1st april 2024 - 31st of january 2026invasive 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)
AKI141st april 2024 - 31st of january 2026) Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern
incidence of failed exam1st april 2024 - 31st of january 2026Percentage of exams successfully performed among the total of patients admitted to study
CKD progression1st april 2024 - 31st of january 2026Incidence of CKD Incidence of CKD Cumulative Incidence of CKD
CRRT1st april 2024 - 31st of january 2026IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026