Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?

NCT01780584 | Completed Phase 2 Results DMC

• 1 other identifier: LB05.01/1.4/235/2010
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low T3 Syndrome

Keywords

congenital heart surgery, thyroid hormones

Outcome Measures

Primary Outcomes (1)

• Free T3 (FT3) Levels

  Free T3 levels were measured up to 36 hours after cross-clamp removal

  during the first 36 hours after cross clamp removal

Secondary Outcomes (1)

• Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.

  Since the first dose of oral T3 until 7 days after surgery

Other Outcomes (3)

• Postoperative Time to Extubation

  up to 3 months after surgery

• Postoperative Length of Stay in Intensive Care Unit

  up to 3 months after surgery

• Postoperative Hospital Length of Stay

  up to 3 month after surgery

Study Arms (3)

Oral T3 low dose & placebo

ACTIVE COMPARATOR

Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)

Drug: Oral T3 Low dose; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)

Drug: Placebo

Oral T3 high dose

EXPERIMENTAL

Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)

Drug: Oral T3 high dose

Interventions

Oral T3 Low dose DRUG

Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h

Also known as: Tetronine

Oral T3 low dose & placebo

Placebo DRUG

Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3

Also known as: Sacharin Lactis

Oral T3 low dose & placebo; Placebo

Oral T3 high dose DRUG

Comparison of different dosages of drugs. Oral T3 high dose is 0.5 mcg/kg q12h

Also known as: Tetronine

Oral T3 high dose

Eligibility Criteria

• Age: 1 Day - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 0-2 years of age
• Aristotle score of 6 and above
• underwent cardiac surgery using cardiopulmonary bypass

You may not qualify if:

• birth weight less than 2 kg for neonates
• preoperative tachyarrhythmia or need for anti arrhythmic treatment
• clinical sepsis confirmed by culture
• preoperative renal insufficiency
• known thyroid and metabolic disorder
• any contraindication for oral T3 administration

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Study Sites (1)

Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita Jakarta

Jakarta, DKI Jakarta, 11420, Indonesia

Location

Related Publications (1)

• Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394.

  PMID: 20837917 RESULT

MeSH Terms

Conditions

Euthyroid Sick Syndromes

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

The lack of power to detect differences in clinical outcomes. There was also insufficient power to detect potentially subtle adverse effects of T3 supplementation.

Results Point of Contact

• Title: Dr Eva M Marwali, Principal Investigator
• Organization: Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita

evamarwali@yahoo.com

+62215684085

Study Officials

• Eva M Marwali, MD

  Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita Jakarta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Cardiac Intensivist

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: January 31, 2013
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 8, 2013
• Results First Posted: March 8, 2013

Record last verified: 2013-02

Locations

ID (1)