Hypothyroidism
Conditions
Keywords
Children, Iodinated contrast agents
Brief summary
To investigate the incidence of detected hypothyroidism after iodinated contrast exposure in pediatric patients from birth to 3 years of age (inclusive) in a routine clinical practice setting.
Interventions
Intravascular application
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
Inclusion criteria
\- All children age 0-3 years (inclusive) who are identified of having undergone a radiological examination with intravascular use of an iodinated contrast agent.(e.g. contrast enhanced CT, cardioangiography)
Exclusion criteria
* Congenital Hypothyroidism or other forms of preexisting hypothyroidism * Preexisting thyroid hormone replacement therapy less than three months of observation before the radiological examination (if greater than three months old) * Less than two weeks follow-up available after the contrast exposure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting | Up to one year after iodinated contrast material (ICM) exposure (828 person years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | At first examination | — |
| Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort | Within a range of ±360 days of the first examination | — |
| Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Prior to first examination | — |
| Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) | — |
| Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Up to one year after ICM exposure (828 person years) | — |
| Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) | — |
| Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) | — |
| Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism | Up to one year after ICM exposure (828 person years) | — |
| The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Up to one year after ICM exposure (828 person years) | Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below. |
| Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Up to one year after ICM exposure (828 person years) | — |
Countries
Israel
Participant flow
Recruitment details
This study was a retrospective cohort study, using the data from the years 1998 until 2015 in the database of Maccabi Health Services (Israel).
Pre-assignment details
Between 1.1.1998 and 31.12.2015, 877 participants were identified. After applying exclusion criteria, 34 participants were excluded from the initial cohort and the final cohort consisted of 843 participants.
Participants by arm
| Arm | Count |
|---|---|
| Iodine Contrast Agent The data used for this retrospective cohort study was from the years 1998 until 2015. The study population consisted of children ages 0-3 (inclusive) who have undergone a radiological examination with an iodinated contrast agent (contrast enhanced CT and cardio-angiography). Follow-up for the outcome (hypothyroidism) was for up to one year after contrast exposure. Incident cases of hypothyroidism were detected by: TSH levels, coded diagnosis of hypothyroidism or start of new thyroid replacement therapy. | 843 |
| Total | 843 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 27 |
Baseline characteristics
| Characteristic | Iodine Contrast Agent |
|---|---|
| Age, Continuous | 1.06 Years STANDARD_DEVIATION 0.87 |
| Comorbidity Cancer | 21 Participants |
| Comorbidity Cardio | 495 Participants |
| Comorbidity Diabetes | 1 Participants |
| Comorbidity Overweight | 12 Participants |
| Dispenses of hypothyroidism inducing drugs Amiodarone | 5 Participants |
| Dispenses of hypothyroidism inducing drugs Anticonvulsants | 21 Participants |
| Sex: Female, Male Female | 382 Participants |
| Sex: Female, Male Male | 461 Participants |
| Sum of Examinations 1 | 775 Participants |
| Sum of Examinations >= 2 | 68 Participants |
| Time between examinations First and second | 282.79 Days STANDARD_DEVIATION 252.34 |
| Time between examinations Second and third | 208.19 Days STANDARD_DEVIATION 180.01 |
| Time between examinations Third and fourth | 212.00 Days STANDARD_DEVIATION 196.28 |
| Type of 1st examination Cardio-angiography | 481 Participants |
| Type of 1st examination CT | 362 Participants |
| Type of >=2nd examination Cardio-angiography | 47 Participants |
| Type of >=2nd examination CT | 21 Participants |
| Weight | 8.80 Kilograms STANDARD_DEVIATION 3.39 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting
Time frame: Up to one year after iodinated contrast material (ICM) exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Iodine Contrast Agent | Number of Pediatric Patients With Detected Hypothyroidism After Iodinated Contrast Exposure in a Routine Clinical Practice Setting | 11 Participants |
Secondary
Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: At first examination
Population: Final Cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 1.07 Years | Standard Deviation 0.86 |
| Hypothyroidism Indication | Baseline Characteristics (Age) of the Cases With Hypothyroidism and of the Rest of the Cohort | 0.53 Years | Standard Deviation 0.96 |
Secondary
Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Prior to first examination
Population: Final Cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Cardio | 485 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Diabetes | 1 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Cancer | 21 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Overweight | 12 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Overweight | 0 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Cardio | 10 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Cancer | 0 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Comorbidity) of the Cases With Hypothyroidism and of the Rest of the Cohort | Diabetes | 0 Participants |
Secondary
Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Male | 454 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Female | 378 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Male | 7 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Sex) of the Cases With Hypothyroidism and of the Rest of the Cohort | Female | 4 Participants |
Secondary
Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | 1 | 765 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | >=2 | 67 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | 1 | 10 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Sum of Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | >=2 | 1 Participants |
p-value: 0.9Chi-squared
Secondary
Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Second and third | 208.19 Days | Standard Deviation 180.01 |
| Iodine Contrast Agent | Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | Third and fourth | 212.00 Days | Standard Deviation 196.28 |
| Iodine Contrast Agent | Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | First and second | 282.72 Days | Standard Deviation 254.24 |
| Hypothyroidism Indication | Baseline Characteristics (Time Between Examinations) in Cases With an Indication of Hypothyroidism and Cases Without | First and second | 288 Days | — |
Secondary
Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Cardio-angiography | 471 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | CT | 361 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Cardio-angiography | 10 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Type of 1st Examination) in Cases With an Indication of Hypothyroidism and Cases Without | CT | 1 Participants |
p-value: 0.022Chi-squared
Secondary
Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Cardio-angiography | 46 Participants |
| Iodine Contrast Agent | Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | CT | 21 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | Cardio-angiography | 1 Participants |
| Hypothyroidism Indication | Baseline Characteristics (Type of 2nd Examination) in Cases With an Indication of Hypothyroidism and Cases Without | CT | 0 Participants |
Secondary
Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort
Time frame: Within a range of ±360 days of the first examination
Population: Final Cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iodine Contrast Agent | Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort | 8.84 Kilograms | Standard Deviation 3.37 |
| Hypothyroidism Indication | Baseline Characteristics (Weight) of the Cases With Hypothyroidism and of the Rest of the Cohort | 6.57 Kilograms | Standard Deviation 3.74 |
Secondary
The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category
Based on the information collected from the database, the probable longest duration of Hypothyroidism was ascertained for the cases below.
Time frame: Up to one year after ICM exposure (828 person years)
Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 2 | NA Months |
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 3 | 2 Months |
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 6 | NA Months |
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 10 | 2 Months |
Secondary
The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category
Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.
Time frame: Up to one year after ICM exposure (828 person years)
Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 4 | 4 Months |
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 7 | 10 Months |
Secondary
The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category
Based on the information collected from the database, the probable shortest duration of Hypothyroidism was ascertained for the cases below.
Time frame: Up to one year after ICM exposure (828 person years)
Population: Probable iodine-induced hypothyroidism: (N=8) included all potential cases of hypothyroidism with no other cause than the previous ICM exposure could be identified.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 5 | 14 Days |
| Iodine Contrast Agent | The Duration of Hypothyroidism Episode in the Probable Iodine Induced Category | Case number 11 | 8 Days |
Secondary
Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism
Time frame: Up to one year after ICM exposure (828 person years)
Population: Final Cohort
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Iodine Contrast Agent | Time-relation Between Iodine Contrast Exposure and Diagnosis of Hypothyroidism | 76.54 Days | Standard Deviation 93.05 |