Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT06909227
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-03-27', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative complications occurring within 3 months after surgery', 'timeFrame': 'within 3 months after surgery', 'description': 'ICU admission Re-operation Re-admission Death'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'anesthesia', 'lactate', 'complications'], 'conditions': ['General Anesthesia', 'Infant']}, 'referencesModule': {'references': [{'pmid': '38313014', 'type': 'BACKGROUND', 'citation': 'Zheng D, Yu GL, Zhou YP, Zhang QM, Wang CG, Zhang S. Association between lactic acidosis and multiple organ dysfunction syndrome after cardiopulmonary bypass. PeerJ. 2024 Jan 31;12:e16769. doi: 10.7717/peerj.16769. eCollection 2024.'}, {'pmid': '32294015', 'type': 'BACKGROUND', 'citation': 'Stephens EH, Epting CL, Backer CL, Wald EL. Hyperlactatemia: An Update on Postoperative Lactate. World J Pediatr Congenit Heart Surg. 2020 May;11(3):316-324. doi: 10.1177/2150135120903977.'}]}, 'descriptionModule': {'briefSummary': 'This study will investigate if the dosage of veinous lactate at the end of a surgical procedure is related to post-operative complications occurring within 3 months in young infants aged 0-1 years.\n\nBlood samples are acquired routinely before emergence of general anesthesia, from the IV line put in place for anesthesia.\n\nThe investigators hypothesized that elevated lactates would be associated with more postoperative complications in this population, as is the case in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '1 Year', 'minimumAge': '0 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children requiring a surgical procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgery under general anesthesia\n* age \\< 1 year\n\nExclusion Criteria:\n\n* ambulatory surgery\n* cardiac surgery\n* preoperative hemodynamic instability\n* Weight \\< 2 kg'}, 'identificationModule': {'nctId': 'NCT06909227', 'acronym': 'PLANN', 'briefTitle': 'Relevance of Veinous Lactates to Predict Postoperative Complications in Children 0-1 Years', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Armand Trousseau'}, 'officialTitle': 'Relevance of Veinous Lactates Dosage at the End of a Surgical Procedure to Predict Postoperative Complications in Children 0-1 Years', 'orgStudyIdInfo': {'id': 'PLANN'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infants 0-1 years undergoing surgery under general anesthesia', 'description': 'Not including day-case surgery, or cardiac surgery', 'interventionNames': ['Procedure: surgery under general anesthesia']}], 'interventions': [{'name': 'surgery under general anesthesia', 'type': 'PROCEDURE', 'description': 'Only in children, \\< 1 year old non-cardiac surgery', 'armGroupLabels': ['infants 0-1 years undergoing surgery under general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75012', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mireille Nasr, MD', 'role': 'CONTACT', 'email': 'mireille.nasr@aphp.fr', 'phone': '+33667601819'}, {'name': 'Mireille Nasr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Armand Trousseau University Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Mireille Nasr, MD', 'role': 'CONTACT', 'email': 'mireille.nasr@aphp.fr', 'phone': '+33667601819'}, {'name': 'Nada Sabourdin, MD, PhD', 'role': 'CONTACT', 'email': 'nada.sabourdin@aphp.fr', 'phone': '+33667185789'}], 'overallOfficials': [{'name': 'Nada Sabourdin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Armand Trousseau University Hospital'}, {'name': 'Isabelle Constant, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Armand Trousseau University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will have to check adherence to confidentiality protocols.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Armand Trousseau', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology, Head of Department', 'investigatorFullName': 'Pr Isabelle CONSTANT', 'investigatorAffiliation': 'Hôpital Armand Trousseau'}}}}