Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2026-02-22 @ 4:51 PM
Study NCT ID:
NCT06476860
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-21', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of proteinuria in the first 24 hours (H0 and H24) of septic shock.', 'timeFrame': '24 hours', 'description': 'relationship between proteinuria kinetics in the first 24 hours (H0 and H24) of septic shock and presence of ARDS at H72'}], 'secondaryOutcomes': [{'measure': 'measurement of albuminuria urinary IgG at H0 and H24', 'timeFrame': '24 hours', 'description': 'Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality'}, {'measure': 'measurement of alpha-1-microglobulin at H0 and H24', 'timeFrame': '24 hours', 'description': 'Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality'}, {'measure': 'measurement of urinary IgG at H0 and H24', 'timeFrame': '24 hours', 'description': 'Evaluation of the association between proteinuria kinetics and the onset of hemodynamic failure, renal failure, duration of mechanical ventilation, ICU stay, and hospital mortality'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['proteinuria', 'septic shock', 'sepsis', 'Acute Respiratory Distresse Syndrome'], 'conditions': ['Sepsis and Septic Shock']}, 'referencesModule': {'references': [{'pmid': '30582882', 'type': 'RESULT', 'citation': 'Iba T, Levy JH. Derangement of the endothelial glycocalyx in sepsis. J Thromb Haemost. 2019 Feb;17(2):283-294. doi: 10.1111/jth.14371. Epub 2019 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'ARDS is a pulmonary edema injury. Among its etiologies, it can be secondary to septic shock. Managing septic shock involves hemodynamic optimization with significant fluid and sodium inputs. Fluid and sodium inputs in ARDS worsen respiratory failure through capillary leakage, and a restrictive input strategy is clinically beneficial (reduced mechanical ventilation duration and ICU stay). Predicting ARDS onset in septic shock allows for optimized fluid and sodium input management, adopting a restrictive rather than liberal approach to minimize deterioration in respiratory function.', 'detailedDescription': 'Septic shock remains highly fatal, causing multi-organ failure including hemodynamic, pulmonary, neurological, renal, hematologic, and hepatic. These failures stem from generalized inflammatory aggression leading to endothelial dysfunction, especially at the capillary level. Pulmonary failure secondary to septic shock is characterized by edema, with ARDS being the most severe form. Sepsis is the second most common cause of ARDS after pneumonia. The incidence of ARDS in severe sepsis is about 6%, and its occurrence is an independent factor contributing to increased mortality.\n\nThese failures significantly impact the management of septic shock, where early and often agressive, vascular filling is standard for hemodynamic failure. Conversely, the onset of ARDS onset warrants limiting hydro-sodium inputs. Currently, there are no data predicting the occurrence of ARDS patients with septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients suspected of sepsis or septic shock until 100 patients are enrolled. Infection diagnosis is based on systemic clinical signs (fever) or local inflammatory signs, biological evidence, and suspicion or confirmation of an infectious agent. The diagnosis of sepsis involves infection accompanied by organ failure, which may manifest as cardiovascular, respiratory, neurological, metabolic, renal, coagulation, or hepatic impairment. These signs may precede hypotension or occur without it.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients aged 18 and older admitted to the intensive care unit for suspected sepsis or septic shock.\n\nExclusion Criteria:\n\n* Minors or opposition to participation.\n* Chronic dialysis patients\n* Organ transplant recipients\n* Confirmed urinary tract infection\n* Subject with macroscopic hematuria\n* Pregnant woman'}, 'identificationModule': {'nctId': 'NCT06476860', 'acronym': 'ALBUREA', 'briefTitle': 'Proteinuria During Sepsis and Septic Shock: Characterization and Association With ARDS', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal André Grégoire'}, 'officialTitle': 'Proteinuria During Sepsis and Septic Shock: Characterization and Association With Acute Respiratory Distress Syndrome', 'orgStudyIdInfo': {'id': 'GHT_CHIM RNI20221130'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients suspected of sepsis or septic shock'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93100', 'city': 'Montreuil', 'country': 'France', 'facility': 'CHI Andre Gregoire', 'geoPoint': {'lat': 48.86415, 'lon': 2.44322}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal André Grégoire', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}