Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT01349218
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2011-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006947', 'term': 'Hyperkalemia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2011-05-03', 'studyFirstSubmitQcDate': '2011-05-05', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Potassium Measurements', 'timeFrame': '0-30 minutes after start of surgery', 'description': 'In this prospective study, we would like to evaluate whether there is a correlation between the potassium level in blood samples drawn from a vein and those drawn from a heel stick.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Potassium', 'Infants', 'Heel Stick', 'Less than or equal to 6 months of age', 'IV catheter blood samples', 'perioperatively', 'elective surgical procedures'], 'conditions': ['Hyperkalemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out whether there is a correlation (link) between the level of potassium in blood samples drawn from a vein and those drawn from a heel stick in infants scheduled for elective surgery.', 'detailedDescription': "This is a prospective study which will take place at the Children's Memorial Hermann Hospital Operating Room.\n\nAfter obtaining written informed consent from parents or guardians, infants and babies scheduled to have elective surgery under routine general anesthesia and are \\<6 months of age will be included in the study. After the baby receives routine general anesthesia, a small amount of blood, 0.5 ml, will be drawn from a vein when an I.V. is started for the surgery. The largest possible cannula will be placed whenever possible to decrease hemolysis. If a baby has a central line, the blood sample will be drawn from it. If a baby has an existing peripheral I.V., a blood sample will be drawn from the I.V. cannula only if blood is freely running, to avoid hemolysis.\n\nBlood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml, will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis. The heel will be properly sterilized, and a proper size lancet will be used. The same operator will be performing the heel stick in each case."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Infants and babies, ASA physical Status I-III, less than 6 month of age and scheduled to have elective surgery under routine general anesthesia at Children's Memorial Hermann Hospital will be included.\n\nExclusion Criteria:\n\n* Babies and infants with documented anemia (\\< 8 gm), who are bleeding, ASA Classification \\>III, have sickle cell disease or trait, thalassemia, HIV or DIC will be excluded from the study. Babies with organ failure will be excluded."}, 'identificationModule': {'nctId': 'NCT01349218', 'acronym': 'PS', 'briefTitle': 'Relationship Between Potassium Level in Venous Blood Samples Drawn and Heel Sticks In Infants and Newborns', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'In Infants and Newborns, is There a Relation Between the Potassium Level in Blood Samples Drawn From a Vein and Those Drawn From a Heel Stick?', 'orgStudyIdInfo': {'id': 'HSC-MS-10-0180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood sample drawn from a vein and from a heel stick', 'description': '0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis. A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.', 'interventionNames': ['Other: Blood sample drawn from a vein', 'Other: Blood sample drawn from a heel stick']}], 'interventions': [{'name': 'Blood sample drawn from a vein', 'type': 'OTHER', 'description': '0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis.', 'armGroupLabels': ['Blood sample drawn from a vein and from a heel stick']}, {'name': 'Blood sample drawn from a heel stick', 'type': 'OTHER', 'description': 'A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.', 'armGroupLabels': ['Blood sample drawn from a vein and from a heel stick']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Samia N Khalil, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Memorial Hermann Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor - Anesthesiology', 'investigatorFullName': 'Samia Khalil', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}