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Not yet recruitingNCT06302192RED-AKIUpdated Mar 8, 2024

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

An observational study in Acute Kidney Injury and ARDS, Human, sponsored by Policlinico Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-03-08.

Sponsored by Policlinico Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
164
Ages
18 Years to 80 Years
Sex
All
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Study 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
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Conditions studied

  • Acute Kidney Injury
  • ARDS, Human

Keywords

  • Renal Doppler
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In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 164 is close to the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Policlinico Hospital is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
  • > 24 hours
  • signed

Exclusion criteria

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
  • ≥ 35
  • Patients needing of VV-ECMO and VA-ECMO
  • Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)
  • \<24 hours
  • Cardio Circulatory Arrest
  • Neoplasm in chemotherapy/radiotherapy
  • Do Not Resuscitate or Comfort Measures
  • Pregnancy at ICU admission
  • Refused by the patient or surrogate decision-maker
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
164 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

  • Diagnostic testARDS+AKI

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

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What researchers measure

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 2026

Secondary 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 2026

  2. 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 2026

  3. 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 2026

  4. 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 2026

  5. incidence of failed exam

    Percentage of exams successfully performed among the total of patients admitted to study

    Time frame: 1st april 2024 - 31st of january 2026

  6. CKD progression

    Incidence of CKD Incidence of CKD Cumulative Incidence of CKD

    Time frame: 1st april 2024 - 31st of january 2026

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06302192
Lead sponsor
Policlinico Hospital
Responsible party
Giacomo Grasselli (Professor, Policlinico Hospital) — Principal investigator
First posted
Mar 8, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Mar 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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