Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-25 @ 4:07 PM
Study NCT ID:
NCT04491357
Status:
UNKNOWN
Last Update Posted:
2020-07-31
First Post:
2020-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006996', 'term': 'Hypocalcemia'}], 'ancestors': [{'id': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002125', 'term': 'Calcium Gluconate'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D005942', 'term': 'Gluconates'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2020-07-24', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of hypocalcaemia after total thyroidectomy', 'timeFrame': 'first 48 hours after total thyroidectomy', 'description': 'To determine whether prophylactic infusion of calcium gluconate reduces the rate of hypocalcaemia after total thyroidectomy compared to placebo treatment'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'first 48 hours after total thyroidectomy', 'description': 'To determine whether prophylactic infusion of calcium gluconate reduces the length of hospital stay compared to placebo group'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypocalcaemia', 'Total thyroidectomy', 'Calcium gluconate'], 'conditions': ['Hypocalcemia']}, 'referencesModule': {'references': [{'pmid': '39282041', 'type': 'DERIVED', 'citation': 'Khoo KS, Yeo A, Mirzan Asfian MRB, Ng KL. The use of prophylactic infusion of calcium gluconate compared to placebo in reducing the rate of early hypocalcaemia after total thyroidectomy: a double-blinded, randomized controlled trial. Gland Surg. 2024 Aug 31;13(8):1378-1386. doi: 10.21037/gs-24-190. Epub 2024 Aug 28.'}]}, 'descriptionModule': {'briefSummary': 'Post-total thyroidectomy hypocalcaemia is a common complication with the rate ranging from 13-49% in a meta-analysis. However, the rate in UMMC in 2018 and 2019 were 40% and 23% respectively. It lead to prolonged hospital stay and patient dissatisfaction in the event of hypocalcaemia.\n\nResearch question: Does prophylactic intravenous calcium infusion reduces the rate of post-total thyroidectomy hypocalcaemia? This study will conduct in UMMC endocrine surgery unit with the target population who scheduled for total thyroidectomy in UMMC between 1/6/2020-1/6/2022.\n\nAfter obtaining consent from participants, they will be randomised into intervention and placebo group with the ratio of 1:1. Intervention group will receive the intravenous calcium gluconate infusion and placebo group will receive saline infusion within 4 hour of skin closure. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery. Both groups will receive same oral calcium supplements.', 'detailedDescription': 'All participating patients will be randomised into intervention and placebo arm with 1:1 ratio. Intervention group will receive 1 ampoule of intravenous calcium gluconate within 4 hours of post total thyroidectomy, whereas the placebo group will received 100ml of normal saline only. Both groups will receive same oral calcium supplements post surgery. Both groups will have their serum calcium measure at 6,12,24,36,48-hour mark post surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-80 years old\n* Scheduled for total thyroidectomy in UMMC\n\nExclusion Criteria:\n\n* Their age outside the range of 18-80\n* Have parathyroid disorders or end stage renal failure\n* On calcium or vitamin D supplements prior to surgery\n* Have deranged calcium homeostasis (outside the normal range of 2.2-2.6 mmol/L)\n* Scheduled for total thyroidectomy plus lymph node dissection'}, 'identificationModule': {'nctId': 'NCT04491357', 'briefTitle': 'Prophylactic Infusion of Calcium Gluconate Reducing the Rate of Hypocalcaemia After Total Thyroidectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'The Use of Prophylactic Infusion of Calcium Gluconate Compared to Placebo in Reducing the Rate of Hypocalcaemia After Total Thyroidectomy: A Double-Blinded, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2020225-8316'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Intervention arm will receive 1 ampoule of intravenous calcium gluconate within 4 hours of skin closure post total thyroidectomy', 'interventionNames': ['Drug: Calcium Gluconate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo arm', 'description': 'Placebo arm will receive 100ml of normal saline within 4 hours of skin closure post total thyroidectomy', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Calcium Gluconate', 'type': 'DRUG', 'otherNames': ['Intravenous calcium gluconate'], 'description': 'Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy', 'armGroupLabels': ['Intervention arm']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Normal saline within 4 hours of skin closure after total thyroidectomy', 'armGroupLabels': ['Placebo arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Kah Seng Khoo', 'role': 'CONTACT', 'email': 'kahseng901209@gmail.com', 'phone': '+60172489272'}, {'name': 'Department of Surgery University of Malaya', 'role': 'CONTACT', 'email': 'fomadmin@um.edu.my', 'phone': '03-7967 6695'}], 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Kah Seng Khoo', 'role': 'CONTACT', 'email': 'kahseng901209@gmail.com', 'phone': '+60172489272'}], 'overallOfficials': [{'name': 'Kah Seng Khoo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Not to share IPD to other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgical Resident, Department of Surgery, Principal Investigator', 'investigatorFullName': 'Khoo Kah Seng', 'investigatorAffiliation': 'University of Malaya'}}}}