Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-07 @ 1:25 AM
Study NCT ID:
NCT06302192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'on day #1, on day #3, on day #7 and on day #14 any 3 ml of urine and 3 ml of blood will be stocked'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 164}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative incidence', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': 'Cumulative incidence of AKI within 7 days from the ARDS onset in demodulated and no-demodulated group'}], 'secondaryOutcomes': [{'measure': 'AKI14', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': ') Incidence of AKI within 14 days from the ARDS onset in patient with and without IRVF demodulated or with different IRVF pattern'}, {'measure': 'AKIstage', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': 'VM, RIhil and RIintra, SI, VexUS values in AKI and no AKI patients and in the different AKI stage'}, {'measure': 'cross talk lung-kidney', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': '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)'}, {'measure': 'CRRT', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': 'IRVF pattern (continuous, pulsatility, biphasic, monophasic), VM, RIhil and RIintra, IRVFhil, SI and VexUS at the beginning and at the discontinuation of CRRT'}, {'measure': 'incidence of failed exam', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': 'Percentage of exams successfully performed among the total of patients admitted to study'}, {'measure': 'CKD progression', 'timeFrame': '1st april 2024 - 31st of january 2026', 'description': 'Incidence of CKD Incidence of CKD Cumulative Incidence of CKD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Doppler'], 'conditions': ['Acute Kidney Injury', 'ARDS, Human']}, 'descriptionModule': {'briefSummary': 'This is a multicenter international observational prospective cohort study. The main questions it aims to answer are:\n\n* 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\n* 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with diagnosis of ARDS admitted to intensive care unit and undergoing invasive mechanical ventilation (IMV).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Critically ill patients admitted to intensive care unit with a diagnosis of ARDS according to Berlino criteria\n* Beginning of IMV less than 48 hours or Clinical decision to begin IMV.\n* Life expectancy \\> 24 hours\n* Informed consent signed\n\nExclusion Criteria:\n\nNo patient will be excluded from the study because of gender, race, ethnicity, or sexual preference.\n\n* AKI prior to the onset of ARDS\n* Chronic respiratory failure due to chronic respiratory diseases\n* Chronic renal disease (CKD stage ≥ 2) and any ureteral obstruction. Definition of CKD patient is according to the latest guideline KDIGO\n* Chronic Heart Failure\n* Chronic liver disease\n* Major trauma in the past 3 months\n* Major surgery in the past 3 months\n* Smoking and Alcohol drinking\n* BMI ≥ 35\n* Patients needing of VV-ECMO and VA-ECMO\n* Beginning of positive pressure ventilation more than 48 hours (invasive or no invasive)\n* Life expectancy \\<24 hours\n* Cardio Circulatory Arrest\n* Neoplasm in chemotherapy/radiotherapy\n* Do Not Resuscitate or Comfort Measures\n* Pregnancy at ICU admission\n* Refused Informed Consent by the patient or surrogate decision-maker'}, 'identificationModule': {'nctId': 'NCT06302192', 'acronym': 'RED-AKI', 'briefTitle': 'Renal Doppler to Predict Acute Kidney Injury (AKI) in ARDS Patients. (RED-AKI Study)', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': '4302'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ARDS+AKI', 'type': 'DIAGNOSTIC_TEST', 'description': 'according to the clinical practice Reanl doppler and VeXUS score will be performed'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giacomo Grasselli', 'investigatorAffiliation': 'Policlinico Hospital'}}}}