Who is sponsoring NCT02521168?

NCT02521168 is sponsored by National Cardiovascular Center Harapan Kita Hospital Indonesia.

What drugs are being tested in NCT02521168?

Interventions in NCT02521168: Oral triiodothyronine, Placebo.

What condition does NCT02521168 study?

NCT02521168 studies Postoperative; Dysfunction Following Cardiac Surgery.

Is NCT02521168 still recruiting?

NCT02521168 is currently completed. Last updated 16 February 2016.

Last reviewed 2016-02-16 · How we verify

NCT02521168: OTICC

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

Oral Triiodothyronine for Children Undergoing Cardiopulmonary Bypass in Indonesia

Completed Phase 3 Last updated 16 February 2016

What this trial tests

Phase 3 trial testing Oral triiodothyronine in Postoperative; Dysfunction Following Cardiac Surgery in 177 participants. Completed in 1 January 2015.

Timeline

1 July 2013

Primary endpoint
1 October 2014

1 January 2015

Quick facts

Lead sponsor	National Cardiovascular Center Harapan Kita Hospital Indonesia
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	177
Start date	1 July 2013
Primary completion	1 October 2014
Estimated completion	1 January 2015
Sites	1 location across Indonesia

Drugs / interventions tested

Oral triiodothyronine
Placebo

Conditions studied

Postoperative; Dysfunction Following Cardiac Surgery — all drugs for Postoperative; Dysfunction Following Cardiac Surgery →

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Who can join

Adults 1 Day to 36 Months, any sex, with Postoperative; Dysfunction Following Cardiac Surgery. 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.

Intubation time
Time frame: Until patients extubated after surgery in ICU OR died OR still intubated within 7 days
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

Sponsor's own description

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.

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 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 NCT02521168 (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: 16 February 2016

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/NCT02521168.

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