Clinical trial NCT06302192: Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
ARDS, Human
Keywords: Renal Doppler
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).

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


Eligibility criteria: 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

Primary outcomes:
measure: cumulative incidence
timeFrame: 1st april 2024 - 31st of january 2026
Secondary outcomes:
measure: AKI14
timeFrame: 1st april 2024 - 31st of january 2026
measure: AKIstage
timeFrame: 1st april 2024 - 31st of january 2026
measure: cross talk lung-kidney
timeFrame: 1st april 2024 - 31st of january 2026
measure: CRRT
timeFrame: 1st april 2024 - 31st of january 2026
measure: incidence of failed exam
timeFrame: 1st april 2024 - 31st of january 2026
measure: CKD progression
timeFrame: 1st april 2024 - 31st of january 2026
Other outcomes:
Locations:
Study officials:
References: