Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 6:06 PM
Study NCT ID:
NCT05111132
Status:
UNKNOWN
Last Update Posted:
2023-01-23
First Post:
2021-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-20', 'studyFirstSubmitDate': '2021-10-27', 'studyFirstSubmitQcDate': '2021-11-05', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of fluid challenge on quadricipital NIRS', 'timeFrame': '6 hours', 'description': 'We will assess the effect of fluid challenge on muscular quadricipital in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)'}, {'measure': 'Effect of fluid challenge on deltoid NIRS', 'timeFrame': '6 hours', 'description': 'We will assess the effect of fluid challenge on muscular deltoid NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)'}, {'measure': 'Effect of fluid challenge on cerebbral NIRS', 'timeFrame': '6 hours', 'description': 'We will assess the effect of fluid challenge on cerebral NIRS in correlation with validated parameters for fluid therapy (dynamic parameters measured by ultrasound: IVC distensibility indec, Vmax aorta)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study will be conducted on pediatric patients up to 14 years of age. The effect of two fluid challenge regimes on cerebral and peripheral NIRS will be assessed, in a randomized double blinded controlled trial. The findings will be correlated with two ultrasound measures, previously validated as markers of fluid responsiveness.', 'detailedDescription': 'The patients will be recruited during the preoperative consultation. After inhalational induction and placement of all monitors, an intravenous access is established. After induction and securing of the airway via endotracheal tube or laryngeal mask, we note the reference values of all parameters. A pre-fluid challenge ultrasound is done, to assess the inferior vena cava distensibillity index, and the Vmax aortic peak flow velocity. After this the fluid challenge is performed. The second ultrasound measures are done after the fluid challenge. Finally an ultrasound is performed at the end of the operation, before emergence, to assess wether the standard peroperative fluid therapy has affecter these measures. NIBP, SpO2, HR, RR, NIRS values will be noted throughout the whole perioperative period. THe end-goald is to correlate the ultrasound findings to the NIRS-values, and see wether the NIRS can be used as a monitor of fluid therapy in pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all operations excepting cardiac surgery\n* BMI \\< 30\n* ages 1-14 years\n\nExclusion Criteria:\n\n* any cardiac affection (congenital unoperated heart disease, arrythmias)\n* icterus\n* refusal'}, 'identificationModule': {'nctId': 'NCT05111132', 'briefTitle': 'Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Can Peripheral NIRS Predict the Response to a Fluid Challenge in Pediatric Patients: An Interventional Study', 'orgStudyIdInfo': {'id': 'P2021/055/CCB B4062021000019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '7.5 ml/kg', 'description': 'Group 1, receiving a fluid challenge of 7,5 ml/kg in 5 minutes', 'interventionNames': ['Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)']}, {'type': 'EXPERIMENTAL', 'label': '12.5 ml/kg', 'description': 'Group 2, 12.5 ml/kg of fluid challenge in 5 minutes', 'interventionNames': ['Diagnostic Test: Fluid challenge (cristalloïd, NaCl 0,9%)']}], 'interventions': [{'name': 'Fluid challenge (cristalloïd, NaCl 0,9%)', 'type': 'DIAGNOSTIC_TEST', 'description': 'A fluid challenge according to group will be administrated by infusion pump', 'armGroupLabels': ['12.5 ml/kg', '7.5 ml/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Pierre Pandin, MD', 'role': 'CONTACT', 'email': 'pierre.pandin@erasme.ulb.ac.be', 'phone': '+3225555812'}], 'facility': 'Erasmus Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Pierre Pandin, MD', 'role': 'CONTACT', 'email': 'Pierre.Pandin@erasme.ulb.ac.be', 'phone': '+3225555812'}], 'overallOfficials': [{'name': 'Pierre Pandin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medical doctor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Lulia Scolobiuc', 'investigatorAffiliation': 'Erasme University Hospital'}}}}