Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT00740727
Status:
COMPLETED
Last Update Posted:
2009-09-11
First Post:
2008-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EASI Access II --- Follow-up Study to the EASI Access Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003681', 'term': 'Dehydration'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephen-thomas@ouhsc.edu', 'phone': '6177267622', 'title': 'Stephen H. Thomas MD MPH', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Successfully Placed EASI Lines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Ability of Basic Life Support (BLS) providers to place EASI access lines.\n\nThe unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.', 'anticipatedPostingDate': '2009-03'}, {'type': 'PRIMARY', 'title': 'Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pain During EASI Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% of subjects with infusion pain', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '1.4', 'ciUpperLimit': '34.7', 'groupDescription': 'This analysis reports the number of subjects (of 18 possible) who experienced pain, during EASI placement or infusion, at the a priori-defined level of at least 3 on a 10-point pain scale.', 'statisticalMethod': '95% binomial exact confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Assessment during EASI placement \\& initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': '% subjects with next-day EASI site pain', 'ciPctValue': '97.5', 'paramValue': '0', 'ciLowerLimit': '0', 'ciUpperLimit': '18.5', 'groupDescription': 'This analysis reports the number of subjects (of 18 possible) who experienced pain, as assessed on next-day follow-up (24 hours after EASI infusion), at the a priori-defined level of at least 3 on a 10-point pain scale.', 'statisticalMethod': 'binomial exact confidence interval', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Because the point estimate was zero, the statistical software (STATA version 10MP) reports a one-sided 97.5% confidence interval.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '2 days', 'description': 'Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.\n\nPresence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received EASI access placement, with co-administration of human recombinant hyaluronidase.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment occurred in January 2009', 'preAssignmentDetails': 'A total of 20 subjects were consented. The study day ran long, so 2 subjects who had consented (and had an initial intravenous {IV} access placed, but no EASI access placed) declined to have any of the study procedures performed since the 2-hour phlebotomy window would have kept them at the study site until the evening.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'EASI/HRH(Human Recombinant Hyaluronidase)', 'description': 'Subjects underwent placement of EASI (Enzymatically Augmented Subcutaneous Infusion) catheters'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-10', 'studyFirstSubmitDate': '2008-08-21', 'resultsFirstSubmitDate': '2009-03-03', 'studyFirstSubmitQcDate': '2008-08-22', 'lastUpdatePostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2009-09-10', 'studyFirstPostDateStruct': {'date': '2008-08-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Successfully Placed EASI Lines', 'timeFrame': '1 day', 'description': 'Ability of Basic Life Support (BLS) providers to place EASI access lines.\n\nThe unit of analysis is the 18 BLS participants (these were also the 18 individuals in whom the EASI access lines were placed).'}, {'measure': 'Systemic Absorption of Subcutaneously Administered Tracer-labelled Glucose', 'timeFrame': '1 day', 'description': 'Number of subjects (out of a possible 18) in whom EASI-administered tracer-labeled glucose was absorbed systemically.Gas chromatography/Mass spectrometry analysis was performed on timed phlebotomy samples, to assess for tracer-labeled glucose.Isotopic glucose enrichment was determined by plasma analysis on a Hewlett-Packard 5985B quadruple mass spectrometer, using + chemical ionization (methane reagent gas). A 12m×0.20mm ID, OV-1 capillary column (He carrier) was used in the gas chromatograph.Enrichments of glucose were calculated as atom percent excess relative to natural background level.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Pain During EASI Infusion', 'timeFrame': '1 day', 'description': 'Assessment during EASI placement \\& initial infusion, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.'}, {'measure': 'Number of Participants With Pain at EASI Infusion Site, on Next-day Follow-up', 'timeFrame': '2 days', 'description': 'Assessment during upon next-day follow-up, for pain as assessed with 10-point scale (0=no pain; 10=worst pain). Significant pain was defined a priori as a pain score of at least 3.\n\nPresence of any pain (yes or no question and then numeric rating if pain was present) was assessed upon follow-up by telephone; on this follow-up a yes/no question was also asked about any complications at infusion site (in the upper back).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Disaster', 'Mass casualty incident', 'Prehospital', 'Rehydration', 'Intravascular access'], 'conditions': ['Disaster Medicine', 'Difficult Intravenous Access', 'Dehydration']}, 'referencesModule': {'references': [{'pmid': '16525142', 'type': 'BACKGROUND', 'citation': 'Sever MS, Vanholder R, Lameire N. Management of crush-related injuries after disasters. N Engl J Med. 2006 Mar 9;354(10):1052-63. doi: 10.1056/NEJMra054329. No abstract available.'}, {'pmid': '12113366', 'type': 'BACKGROUND', 'citation': 'Stafford PW, Blinman TA, Nance ML. Practical points in evaluation and resuscitation of the injured child. Surg Clin North Am. 2002 Apr;82(2):273-301. doi: 10.1016/s0039-6109(02)00006-3.'}, {'pmid': '16876899', 'type': 'BACKGROUND', 'citation': 'Bookbinder LH, Hofer A, Haller MF, Zepeda ML, Keller GA, Lim JE, Edgington TS, Shepard HM, Patton JS, Frost GI. A recombinant human enzyme for enhanced interstitial transport of therapeutics. J Control Release. 2006 Aug 28;114(2):230-41. doi: 10.1016/j.jconrel.2006.05.027. Epub 2006 Jun 7.'}, {'pmid': '18095810', 'type': 'BACKGROUND', 'citation': 'Thomas JR, Yocum RC, Haller MF, von Gunten CF. Assessing the role of human recombinant hyaluronidase in gravity-driven subcutaneous hydration: the INFUSE-LR study. J Palliat Med. 2007 Dec;10(6):1312-20. doi: 10.1089/jpm.2007.0126.'}, {'pmid': '8105720', 'type': 'BACKGROUND', 'citation': 'Beylot M, David F, Brunengraber H. Determination of the 13C-labeling pattern of glutamate by gas chromatography-mass spectrometry. Anal Biochem. 1993 Aug 1;212(2):532-6. doi: 10.1006/abio.1993.1364.'}, {'pmid': '12670856', 'type': 'BACKGROUND', 'citation': 'Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.'}, {'pmid': '17127123', 'type': 'BACKGROUND', 'citation': 'Alam HB, Rhee P. New developments in fluid resuscitation. Surg Clin North Am. 2007 Feb;87(1):55-72, vi. doi: 10.1016/j.suc.2006.09.015.'}, {'pmid': '15605914', 'type': 'BACKGROUND', 'citation': 'Dalal S, Bruera E. Dehydration in cancer patients: to treat or not to treat. J Support Oncol. 2004 Nov-Dec;2(6):467-79, 483.'}, {'pmid': '2956050', 'type': 'BACKGROUND', 'citation': 'Craig AS, Eikenberry EF, Parry DA. Ultrastructural organization of skin: classification on the basis of mechanical role. Connect Tissue Res. 1987;16(3):213-23. doi: 10.3109/03008208709006977.'}, {'pmid': '1742011', 'type': 'BACKGROUND', 'citation': 'Laurent UB, Dahl LB, Reed RK. Catabolism of hyaluronan in rabbit skin takes place locally, in lymph nodes and liver. Exp Physiol. 1991 Sep;76(5):695-703. doi: 10.1113/expphysiol.1991.sp003536.'}, {'pmid': '17683255', 'type': 'BACKGROUND', 'citation': 'Frost GI. Recombinant human hyaluronidase (rHuPH20): an enabling platform for subcutaneous drug and fluid administration. Expert Opin Drug Deliv. 2007 Jul;4(4):427-40. doi: 10.1517/17425247.4.4.427.'}, {'pmid': '22854002', 'type': 'DERIVED', 'citation': 'Soremekun OA, Shear ML, Connolly J, Stewart CE, Thomas SH. Basic-level emergency medical technician administration of fluids and glucose via enzyme-assisted subcutaneous infusion access. Prehosp Disaster Med. 2012 Jun;27(3):220-5. doi: 10.1017/S1049023X12000829.'}]}, 'descriptionModule': {'briefSummary': 'Test whether Basic Life Support (BLS) providers can successfully place Enzymatically Augmented Subcutaneous Infusion (EASI) Access lines for subcutaneous infusion, and characterize intravascular absorption of EASI-administered (tracer-labelled) glucose (D5W).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be at least 18 years of age and have none of the following conditions:\n\n * pregnancy (negative urine pregnancy test to be performed before study participation),\n * diabetes, or coagulopathic (including taking any anticoagulants);\n* Subjects cannot be taking steroids or other immunosuppressants.\n* Because of the potential for reduced hyaluronidase effectiveness, the study excludes patients taking more than 80 mg daily aspirin, as well as any patients taking ACTH, antihistamines, or estrogen other than in oral contraceptive preparations.\n* Subjects will not be required to fast before the study, but will not allowed to eat or drink during the EASI infusion or the phlebotomy sampling time frame.'}, 'identificationModule': {'nctId': 'NCT00740727', 'briefTitle': 'EASI Access II --- Follow-up Study to the EASI Access Trial', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Enzymatically Augmented Subcutaneous Infusion (EASI) Access II Trial', 'orgStudyIdInfo': {'id': 'EASI Access II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EASI', 'description': 'Subjects will undergo placement of EASI catheters. All subjects in whom EASI catheters are placed, will receive Human Recombinant Hyaluronidase (HRH) as part of the EASI placement. (No subject will receive HRH, other than as part of EASI catheter placement.)', 'interventionNames': ['Drug: Human recombinant hyaluronidase (HRH)', 'Procedure: Enzymatically Augmented Subcutaneous Infusion (EASI) line placement']}], 'interventions': [{'name': 'Human recombinant hyaluronidase (HRH)', 'type': 'DRUG', 'otherNames': ['Hylenex'], 'description': '150u HRH administered via EASI access line, prior to infusion of 250 D5W (5% dextrose in water)', 'armGroupLabels': ['EASI']}, {'name': 'Enzymatically Augmented Subcutaneous Infusion (EASI) line placement', 'type': 'PROCEDURE', 'description': 'Subjects will under placement of an EASI line. This entails placement of a small (20-gauge) catheter in the upper back, in the subcutaneous space.', 'armGroupLabels': ['EASI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Stephen H Thomas, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Stephen H. Thomas MD MPH', 'oldOrganization': 'Massachusetts General Hospital/Harvard Medical School'}}}}