Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-27 @ 4:14 PM
Study NCT ID:
NCT06242561
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-29', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total volume of fluids administered during the first 48 hours of ICU stay', 'timeFrame': '48 hours from ICU admission', 'description': 'Total volume of fluids (ml)'}], 'secondaryOutcomes': [{'measure': 'Haemoglobinemia', 'timeFrame': '48 hours from ICU admission', 'description': 'Haemoglobinemia (g/dl)'}, {'measure': 'Type of fluids administered during the first 48 hours of ICU stay', 'timeFrame': '48 hours from ICU admission', 'description': 'resuscitation, nutrition, maintenance // crystalloids, colloids, dextrose, sodium bicarbonate'}, {'measure': 'Volume of fluids administered before admission in ICU (ml)', 'timeFrame': 'at ICU admission', 'description': 'Volume of fluids (ml)'}, {'measure': 'In hospital mortality', 'timeFrame': 'at hospital discharge : an average of 15 days', 'description': 'rate'}, {'measure': 'Length of hospital stay', 'timeFrame': 'at hospital discharge : an average of 15 days', 'description': 'Length of hospital stay (days)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hemoglobin levels'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'This is a single-center retrospective study conducted at Mercy hospital, aiming to investigate the correlation between changes in hemoglobin (Hb) levels and the volume of vascular refill administered during the first 48 hours.', 'detailedDescription': 'Vascular refill is central to the initial management of hypotension in sepsis, and is often started even before the patient is admitted to intensive care. Over the past 20 years, we have moved from ultraliberal fluid resuscitation to restrictive resuscitation. Indeed, in the early 2000s, the implementation of an early and aggressive hemodynamic optimization strategy, including liberal vascular filling, improved the survival of critically ill patients, and ushered in the era of the Surviving Sepsis Campaign. However, studies have shown increased morbidity and mortality associated with a positive fluid balance. Restrictive approaches to fluid resuscitation and/or deressuscitation were then tested. While these approaches failed to demonstrate any benefit in terms of mortality, they did have the merit of demonstrating their feasibility and good tolerability, albeit with a little-explored pathophysiology. Little is known about the problem of dilutional anemia in the acute phase of septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Septic patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with septic shock, admitted to Mercy hospital between November 1, 2022 and July 31, 2023, with Noradrenaline administration for at least 6 hours and at least 2 hemoglobin measurements during the first 48 hours of resuscitation.\n\nExclusion Criteria:\n\n* patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.'}, 'identificationModule': {'nctId': 'NCT06242561', 'acronym': 'QUADS', 'briefTitle': 'Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study: a Preliminary Retrospective Study', 'orgStudyIdInfo': {'id': '2023-14Obs-CHRMT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Data collection from sepsis management', 'type': 'BEHAVIORAL', 'description': 'observational study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville/Hopital Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Damien BARRAUD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital Mercy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "According to the French law and the French Data Protection Authority (CNIL), we won't be able to publicly share individual participant data, but we plan to share their conclusions through peer-reviewed publications and conferences."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}