Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 7:59 PM
Study NCT ID:
NCT05119361
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D004487', 'term': 'Edema'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2021-11-02', 'studyFirstSubmitQcDate': '2021-11-02', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Computed cumulative fluid balance (mL) at day 5 after protocol onset.', 'timeFrame': 'Day 5 after protocol onset.', 'description': 'Cumulative between input and output, defined as follow:\n\n* Input = cumulative volume of:\n\n * Medication\n * Enteral and parenteral feeding\n * Fluid loading\n * Transfusion products\n* Output = cumulative volume of:\n\n * diuresis\n * surgical drainage\n * net ultrafiltration'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ultrafiltration', 'deresuscitation', 'fluid overload', 'fluid balance.'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Fluid overload is frequent and associated with mortality in critically ill patients, especially those with acute kidney injury. If fluid loading is a cornerstone of a resuscitation strategy, some authors promote an evacuation phase to limit the fluid overload exposure (deresuscitation strategy). In patients with continuous renal therapy, often presenting an inadequate diuresis, it includes the net ultrafiltration setting. A potential side effect of deresuscitation strategy is to induce iatrogenic hypovolemia.\n\nWe have implemented a perfusion-based protocol to induce systematic early fluid removal on patients after haemodynamic stabilization. We would like to observe the impact on the fluid balance of such a protocol and to explore the recruitment capacity of our centre and exploratory outcomes to lead a future randomized control study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult Patients in intensive care unit with acute kidney injury with continuous renal replacement therapy and fluid overload, with hemodynamic instability', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Age ≥ 18 ans\n* Acute kidney injury with continuous renal replacement therapy\n* Fluid overload \\> 5%\n* Equivalent Norepinephrine dose \\< 0,5 µg/kg/min\n\nExclusion Criteria:\n\n* \\- Chronic intermittent haemodialysis\n* Active bleeding\n* Stroke with coma\n* Pregnancy\n* advanced directives to withhold or withdraw life-sustaining treatment\n* patient\'s opposition to the use of his/her personal health data."'}, 'identificationModule': {'nctId': 'NCT05119361', 'acronym': 'Early Dry', 'briefTitle': 'Early Dry Cohort : Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit.', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact on the Fluid Balance of a Perfusion Based Protocol to Adjust UFnet During Deresuscitation in Intensive Care Unit. A Before-after Study.', 'orgStudyIdInfo': {'id': '454'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'before protocol implementation', 'description': 'A control group reflecting usual practice about net ultrafiltration and deresuscitation strategy in patients with continuous renal replacement therapy in our Department.\n\nAll patients meeting eligibility criteria between 01/01/2020 and 31/12/2021 will be include.', 'interventionNames': ['Other: Early Dry protocol']}, {'label': 'after protocol implementation', 'description': 'All patients treated by our deresuscitation protocol between 15/02/2020 and 15/08/2021 will be included.', 'interventionNames': ['Other: Early Dry protocol']}], 'interventions': [{'name': 'Early Dry protocol', 'type': 'OTHER', 'description': 'After meeting eligibility criteria, patients have a net ultrafiltration of 2mL/kg/h with systematic perfusion monitoring (lactate concentration, central venous saturation, mottling score and capillary refill time) and restrictive input.\n\nIf the patient presents hypoperfusion (at least to sign), net ultrafiltration is stopped and haemodynamic optimized.\n\nIf the patient presents pulmonary oedema or right ventricular failure, with venous congestion, ultrafiltration is set at 3mL/kg/h.\n\nUltrafiltration is set between 0.5 and 1mL/kg/h when the following criteria are fulfilled: weight inferior to the admission weight; central venous pressure inferior to 5mmHg; absence of clinical oedema.\n\nThe haemodynamic status is reevaluated all six hours.', 'armGroupLabels': ['after protocol implementation', 'before protocol implementation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hôpital cardiologique Louis Pradel - HCL', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}