Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
- Conditions
- Acute Kidney InjuryARDS, Human
- Registration Number
- NCT06302192
- Lead Sponsor
- Policlinico Hospital
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 164
- 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
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method cumulative incidence 1st april 2024 - 31st of january 2026 Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group
- Secondary Outcome Measures
Name Time Method AKIstage 1st april 2024 - 31st of january 2026 VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage
CKD progression 1st april 2024 - 31st of january 2026 Incidence of CKD Incidence of CKD Cumulative Incidence of CKD
cross talk lung-kidney 1st april 2024 - 31st of january 2026 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)
CRRT 1st april 2024 - 31st of january 2026 IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT
incidence of failed exam 1st april 2024 - 31st of january 2026 Percentage of exams successfully performed among the total of patients admitted to study
AKI14 1st 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