Trial Outcomes & Findings for Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children? (NCT NCT01780584)
NCT ID: NCT01780584
Last Updated: 2013-03-08
Results Overview
Free T3 levels were measured up to 36 hours after cross-clamp removal
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
during the first 36 hours after cross clamp removal
Results posted on
2013-03-08
Participant Flow
Subjects recruitment was done from Pediatric Cardiac Intensive Care Unit at the National Cardiovascular Center Harapan Kita, Jakarta, Indonesia between April, 2010 and September, 2010.
There were 47 individuals screened for participation, and consent to participate was obtained from 46 (98%). One subjects from whom did not participate because of surgical postponement. A total of 45 subjects were randomized to 3 groups of 15.
Participant milestones
| Measure |
Placebo
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)
|
Oral T3 Low Dose
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)
|
Oral T3 High Dose
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)
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Placebo
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)
|
Oral T3 Low Dose
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)
|
Oral T3 High Dose
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)
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
Baseline Characteristics
Can Oral T3 Normalize Thyroid Hormone Levels Following Cardiopulmonary Bypass in Children?
Baseline characteristics by cohort
| Measure |
Oral T3 Low Dose
n=15 Participants
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)
|
Placebo
n=15 Participants
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)
|
Oral T3 High Dose
n=15 Participants
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)
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age Continuous
|
0.9 years
STANDARD_DEVIATION 0.5 • n=5 Participants
|
0.8 years
STANDARD_DEVIATION 0.4 • n=7 Participants
|
0.8 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
0.9 years
STANDARD_DEVIATION 0.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
Indonesia
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
45 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: during the first 36 hours after cross clamp removalPopulation: Two subjects (one in T3 low dose and one in T3 high dose) were withdrawn from the treatment protocol. The withdrawal in low dose group was because of severe hypertension caused by a previously unrecognized coarctation of the aorta, and the high dose group withdrawal was due to massive gastrointestinal bleeding.
Free T3 levels were measured up to 36 hours after cross-clamp removal
Outcome measures
| Measure |
Placebo
n=15 Participants
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)
|
Oral T3 Low Dose
n=14 Participants
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)
|
Oral T3 High Dose
n=14 Participants
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)
|
|---|---|---|---|
|
Free T3 (FT3) Levels
hour 0
|
3.6 pg/ml
Standard Error 0.4
|
4.5 pg/ml
Standard Error 0.6
|
3.9 pg/ml
Standard Error 0.2
|
|
Free T3 (FT3) Levels
hour 1
|
3.6 pg/ml
Standard Error 0.3
|
4.1 pg/ml
Standard Error 0.5
|
4.3 pg/ml
Standard Error 0.2
|
|
Free T3 (FT3) Levels
hour 6
|
2.9 pg/ml
Standard Error 0.3
|
3.3 pg/ml
Standard Error 0.3
|
3.7 pg/ml
Standard Error 0.3
|
|
Free T3 (FT3) Levels
hour 18
|
2.4 pg/ml
Standard Error 0.2
|
2.6 pg/ml
Standard Error 0.4
|
3.8 pg/ml
Standard Error 0.4
|
|
Free T3 (FT3) Levels
hour 36
|
1.6 pg/ml
Standard Error 0.2
|
2.1 pg/ml
Standard Error 0.3
|
4.4 pg/ml
Standard Error 0.5
|
SECONDARY outcome
Timeframe: Since the first dose of oral T3 until 7 days after surgeryPopulation: Three patients were excluded from adverse effect analysis. Two patients, each in placebo and high dose group were on Extracorporeal Membrane Oxygenation. One patient in high dose group could not attained enteral feeds due to gastrointestinal bleeding and was withdrawal from the protocol.
Specific symptoms of hyperthyroidism included cardiac dysrhythmia requiring medical or electrical treatment, hypertension (mean systolic or diastolic blood pressure more than 2 standard deviation above normal for age) and hyperthermia (\>37.5 degree Celsius). One patient in low dose group had hypertension directly after surgery due to unrecognized coarctation of the aorta and this patient was withdrawal from the protocol.
Outcome measures
| Measure |
Placebo
n=14 Participants
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)
|
Oral T3 Low Dose
n=15 Participants
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)
|
Oral T3 High Dose
n=13 Participants
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)
|
|---|---|---|---|
|
Number of Patients With Possible Side Effects of Thyroid Hormone Supplementation Particularly Suggesting Hyperthyroid Symptoms.
|
0 participants
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 months after surgeryPostoperative time to extubation is length of time on ventilator.
Outcome measures
| Measure |
Placebo
n=14 Participants
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)
|
Oral T3 Low Dose
n=14 Participants
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)
|
Oral T3 High Dose
n=13 Participants
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)
|
|---|---|---|---|
|
Postoperative Time to Extubation
|
23 hours
Interval 15.0 to 144.0
|
36.5 hours
Interval 5.0 to 794.0
|
17 hours
Interval 8.0 to 224.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 months after surgeryOutcome measures
| Measure |
Placebo
n=14 Participants
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)
|
Oral T3 Low Dose
n=14 Participants
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)
|
Oral T3 High Dose
n=13 Participants
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)
|
|---|---|---|---|
|
Postoperative Length of Stay in Intensive Care Unit
|
48.5 hours
Interval 20.0 to 258.0
|
109.5 hours
Interval 22.0 to 816.0
|
87 hours
Interval 22.0 to 456.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 3 month after surgeryOutcome measures
| Measure |
Placebo
n=14 Participants
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)
|
Oral T3 Low Dose
n=14 Participants
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)
|
Oral T3 High Dose
n=13 Participants
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)
|
|---|---|---|---|
|
Postoperative Hospital Length of Stay
|
6 days
Interval 5.0 to 26.0
|
17.5 days
Interval 2.0 to 34.0
|
10 days
Interval 5.0 to 41.0
|
Adverse Events
Oral T3 Low Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Oral T3 High Dose
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oral T3 Low Dose
n=15 participants at risk
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)
|
Placebo
n=15 participants at risk
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)
|
Oral T3 High Dose
n=15 participants at risk
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)
|
|---|---|---|---|
|
Cardiac disorders
Mortality
|
6.7%
1/15 • Number of events 1 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
6.7%
1/15 • Number of events 1 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
6.7%
1/15 • Number of events 1 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
Other adverse events
| Measure |
Oral T3 Low Dose
n=15 participants at risk
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)
|
Placebo
n=15 participants at risk
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)
|
Oral T3 High Dose
n=15 participants at risk
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)
|
|---|---|---|---|
|
Cardiac disorders
Symptoms of suspected hyperthyroidism
|
0.00%
0/15 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
6.7%
1/15 • Number of events 1 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
0.00%
0/15 • 3 months
Serious adverse events was defined as mortality within 3 months. Other adverse events were symptoms of suspected of hyperthyroidism that observed within 7 days since the study started.
|
Additional Information
Dr Eva M Marwali, Principal Investigator
Pediatric Cardiac ICU National Cardiovascular Center Harapan Kita
Phone: +62215684085
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place