Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-02-04 @ 12:15 PM
Study NCT ID:
NCT02521168
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005067', 'term': 'Euthyroid Sick Syndromes'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014284', 'term': 'Triiodothyronine'}], 'ancestors': [{'id': 'D013970', 'term': 'Thyronines'}, {'id': 'D013963', 'term': 'Thyroid Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D013974', 'term': 'Thyroxine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2015-08-02', 'studyFirstSubmitQcDate': '2015-08-07', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Inotropic and vasoactive-inotropic score', 'timeFrame': '1, 6, 12, 18, 24, 36, 48, 60 and 72 hours post cross clamp removal', 'description': 'The amount of inotropic drugs are calculated and reviewed serially since cross clamp removal until all drugs are stopped'}, {'measure': 'Diuresis', 'timeFrame': 'From day 1 until day 3 post surgery', 'description': 'Amount of urine output per kg body weight per hour'}, {'measure': 'Fluid balance', 'timeFrame': 'From day 1until day 3 post surgery', 'description': 'Difference between input and output of the fluid per kg body weight per day'}, {'measure': 'Lactate-pyruvate ratio', 'timeFrame': 'On induction of anaesthesia, 1 hour, 24 hours post cross clamp removal', 'description': 'Lactate and pyruvate serum was obtained from central venous catheter in internal jugular vein with the distal tip catheter in the right atrium'}, {'measure': 'Ejection Fraction', 'timeFrame': 'Day 1, 2 and 3 post surgery', 'description': 'Ejection Fraction is measured by Echocardiography'}, {'measure': 'Cardiac Index', 'timeFrame': 'Day 1, 2 and 3 post surgery', 'description': 'Cardiac index is measured by Echocardiography'}, {'measure': 'Systemic Vascular Resistance Index', 'timeFrame': 'Day 1, 2 and 3 post surgery', 'description': 'Systemic Vascular Resistance Index is measured by Echocardiography'}, {'measure': 'Pulse Pressure', 'timeFrame': 'Every hourly until 72 hours post surgery', 'description': 'Difference between systolic and diastolic pressure'}, {'measure': 'Number of patients with sepsis', 'timeFrame': 'since day 1 post surgery until patients discharge', 'description': 'Amount of patients diagnosis with sepsis based on Surviving Sepsis Campaign'}], 'primaryOutcomes': [{'measure': 'Intubation time', 'timeFrame': 'Until patients extubated after surgery in ICU OR died OR still intubated within 7 days', 'description': 'All patients after undergoing congenital heart surgery will be supported by mechanical ventilation. Duration of this support since cross clamp off removal until after surgery will be assessed in the treatment and placebo group. Thyroid supplementation will increase the cardiac function and will make the patients extubated early than the patients without supplementation'}], 'secondaryOutcomes': [{'measure': 'Number of patients with low cardiac output syndrome', 'timeFrame': '6 hours, 12 hours, 18 hours, 24 hours, 48 hours post aortic cross clamp removal', 'description': 'Identified patients with low cardiac output syndrome in which had clinical signs and symptoms of low cardiac output are found with without the increasing of arterial and venous gap and metabolic acidosis and this condition needs 100% of inotropic support or even more than that from the beginning of inotropic used, the use of new inotropic, mechanical support, or other manoeuvres in order to increase cardiac output (e.g pacemaker)'}, {'measure': 'Drug adverse reaction', 'timeFrame': 'Every hourly until 12 hours post cross clamp removal, every 3 hours until 24 hours, every 6 hours until 48 hours, every 12 hours until 72 hours post cross clamp removal, and until the patients discharge from hospital', 'description': 'Heart rate to evaluate tachycardia, blood pressure for hypertension, heart rate for arrhythmia, body temperature for hyperthermia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['euthyroid sick syndrome', 'cardiopulmonary bypass', 'congenital heart disease', 'time to extubation'], 'conditions': ['Postoperative; Dysfunction Following Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'A condition of decreased serum T3 level in children after cardiac surgery using cardiopulmonary bypass has been commonly recognized as euthyroid sick syndrome (ESS). This syndrome has been closely associated with low cardiac output syndrome after heart surgery. The unique characteristics of pediatric patients with congenital heart disease (CHD) in Indonesia have caused ESS to arise in the population even before surgical managements. Thyroid hormones increase cardiac function, respiration and diuresis. Increased myocardial function occurred through the improvement of mitochondrial effectiveness as the body energy source by utilizing effective energy substrates, lactate and pyruvate. Prevention of decreased serum thyroid hormones level by T3 supplementation could be clinically beneficial. Intravenous T3 unit dose is very expensive and inapplicable for daily use. In adult studies, oral T3 was found to be effective for the prevention of decreased serum T3 levels; similar study on pediatric population, however, has not been elucidated.', 'detailedDescription': "Methods:\n\nThe study was conducted at the cardiac paediatric cardiac intensive care unit of National Cardiovascular Center Harapan Kita. It was performed on paediatric congenital heart disease population who underwent open heart surgery with randomised, double-blind, controlled trial design. All patients with congenital heart disease, 3 years old or less, were included. Types of congenital heart disease suffered required subject to undergo surgery using cardiopulmonary bypass machine with Aristotle score of 6-9. Surgery was aimed for biventricular repair.\n\nThe sample size needed almost 200 patients with 50% is in the treatment group. This calculation was based on 90% of patients will be extubated and expected hazard ratio of corresponding treatment group is 1.7 with 5% alpha error and 20% beta error.\n\nPatients were randomised using block randomisation procedure. The stratification factor will be age at the time of recruitment: \\< 6 weeks old, 6 weeks - 5 months old, \\> 5 months - 3 years old. Randomization will occur on the day of surgery.\n\nThe placebo - saccharum lactis - OR oral T3 (Tetronine, Dalim Biotech Korea) with the dose of 1 mcg per kg body weight were administered via nasogastric tube for every 6 hours starting from the time of anaesthesia induction until 11 doses in total (60 hours after the initial administration). Serial free T3 (FT3) and thyroid stimulating hormone (TSH) measurement were performed starting from the induction of anaesthesia until patient's discharge. Haemodynamics monitoring and echocardiography evaluation was conducted from day 1 to 3 after the surgery.\n\nStatistical analysis:\n\nPrimary analysis will be performed using Cox Proportional Hazards for time to extubation result, including terms for stratification factors (age, Aristotle score and nutrition status). Patients will be included in analysis if they were randomised and received at least one dose of study drug according to the principal of Intention-to-Treat (ITT)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Months', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children undergoing cardiopulmonary bypass\n* Age 36 months old or less\n* Aristotle score 6-9\n* Total correction or biventricular repair\n\nExclusion Criteria:\n\n* Single ventricle defects\n* Body weight less than 2 kg at the time of recruitment\n* Presentation with sepsis\n* Tachyarrhythmia or any other arrhythmia before surgery\n* Creatinine level of more than 2 mg/dl\n* Known thyroid disease\n* Known lung abnormalities (including infection) before surgery'}, 'identificationModule': {'nctId': 'NCT02521168', 'acronym': 'OTICC', 'briefTitle': 'Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia', 'organization': {'class': 'OTHER', 'fullName': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}, 'officialTitle': 'Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia', 'orgStudyIdInfo': {'id': '164/H2.F1/ETIK/2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral triiodothyronine', 'description': 'Oral T3 (triiodothyronine) is given 1 mcg/kg every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours', 'interventionNames': ['Drug: Oral triiodothyronine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (saccharin lactic) is given every 6 hourly through naso-gastric tube since induction of anaesthesia for 60 hours', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oral triiodothyronine', 'type': 'DRUG', 'otherNames': ['Tetronine', 'Lyothyronine'], 'description': 'Oral triiodothyronine is given peri-operatively through naso-gastric tube', 'armGroupLabels': ['Oral triiodothyronine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saccharin lactis'], 'description': 'Placebo consist of saccharin lactis that has the same appearance as Tetronine', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11420', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Eva M Marwali, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cardiovascular Center Harapan Kita Jakarta'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cardiovascular Center Harapan Kita Hospital Indonesia', 'class': 'OTHER'}, 'collaborators': [{'name': 'CRDF Global', 'class': 'OTHER'}, {'name': 'Osypka Germany', 'class': 'UNKNOWN'}, {'name': 'Dalim BioTech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Eva M Marwali,MD', 'investigatorAffiliation': 'National Cardiovascular Center Harapan Kita Hospital Indonesia'}}}}