NCT01780584 is a Phase 2 clinical trial of Oral T3 Low dose in Low T3 Syndrome, sponsored by National Cardiovascular Center Harapan Kita Hospital Indonesia.

Who is sponsoring NCT01780584?

NCT01780584 is sponsored by National Cardiovascular Center Harapan Kita Hospital Indonesia.

What drugs are being tested in NCT01780584?

Interventions in NCT01780584: Oral T3 Low dose, Placebo, Oral T3 high dose.

What condition does NCT01780584 study?

NCT01780584 studies Low T3 Syndrome.

Is NCT01780584 still recruiting?

NCT01780584 is currently completed. Last updated 2 February 2013.

Are results published for NCT01780584?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2013-02-02 · How we verify

NCT01780584

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Oral Triiodothyronine Normalizes T3 Levels After Surgery For Pediatric Congenital Heart Disease

Completed Phase 2 Results posted Last updated 2 February 2013

What this trial tests

Phase 2 trial testing Oral T3 Low dose in Low T3 Syndrome in 45 participants. Completed in 1 October 2010.

Timeline

1 April 2010

Primary endpoint
1 September 2010

1 October 2010

Quick facts

Lead sponsor	National Cardiovascular Center Harapan Kita Hospital Indonesia
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	45
Start date	1 April 2010
Primary completion	1 September 2010
Estimated completion	1 October 2010
Sites	1 location across Indonesia

Drugs / interventions tested

Oral T3 Low dose — full drug profile →
Placebo
Oral T3 high dose — full drug profile →

Conditions studied

Low T3 Syndrome — all drugs for Low T3 Syndrome →

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Who can join

Adults 1 Day to 24 Months, any sex, with Low T3 Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Free T3 (FT3) Levels
Time frame: during the first 36 hours after cross clamp removal
Free T3 levels were measured up to 36 hours after cross-clamp removal

Sponsor's own description

Low triiodothyronine (T3) syndrome defines as decrease of T3 levels during critically ill. This decrease of T3 levels was observed after congenital heart surgery using cardiopulmonary bypass. Previous largest study,Triiodothyronine for Infants and Children Undergoing Cardiopulmonary bypass (TRICC) study showed T3 supplementation decreased time to extubation for infants less than 5 months undergoing cardiopulmonary bypass. Intravenous regiment was known effective in maintaining T3 levels during pediatric cardiac surgery. This drug preparation however is not commonly used in many countries due to the relatively high costs and/or the simple lack of availability. The use of oral T3 to treat postoperative low T3 levels in pediatric patients has not been reported so far, although recent adult studies showed benefit in using oral T3 after cardiac surgery. The purpose of this study was to determine if oral T3 supplementation could prevent the decline of serum T3 in children less than 2 years of age undergoing congenital heart surgery using CPB.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Low T3 Syndrome

Currently open trials in the same condition.

NCT06353555 — Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage · NA · recruiting

Other National Cardiovascular Center Harapan Kita Hospital Indonesia trials

Trials by the same sponsor.

NCT06091982 — Renal Replacement Therapy and In-Hospital Mortality Incidence in Cardiac Surgery Associated Acute Kidney Injury · completed
NCT05579964 — The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot · Phase 2, PHASE3 · completed
NCT06766045 — Comparison of Ultrasound with Fluoroscopy to Assess Diaphragmatic Paralysis After Congenital Heart Disease Surgery · NA · completed
NCT05622292 — The Effectivity of the Mobile App "HARKIT I-Care" in Secondary Prevention in Post-ACS Patients · NA · unknown
NCT05300802 — The Role of Dexmedetomidine As Myocardial Protection In Pediatric Cyanotic Congenital Heart Disease Undergoing Open Card · Phase 2, PHASE3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01780584 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cardiovascular Center Harapan Kita Hospital Indonesia
Last refreshed: 2 February 2013

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01780584.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing