Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage

NCT ID: NCT06353555

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2025-12-31

Brief Summary

Low levels of serum triiodothyronine (T3) thyroid hormones (T4) are a strong predictor of mortality and poor prognosis in critical care patients. Few reports, however, have focused on neurocritical patients.

Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates, and many studies have provided evidence for a low T3/T4 state being an important prognostic indicator in such cases; Lieberman et al. found that 87% of individuals with severe traumatic brain injury have thyroid function below the mid-normal range. Other researchers showed that low T3 syndrome is a predictor of poor prognosis in cerebral infarction patients; their findings indicated the central hypothyroidism and disturbance of thyroid hormone metabolism were involved. Low T3 syndrome is common in patients with brain tumors and has been shown to be associated with shorter survival in glioma patients. Despite these observations, however, whether the thyroid hormone abnormalities in the critically ill are a physiological adaptation or a pathological change, and whether hormone replacement therapy (HRT) can benefit such patients, remain to be established.

As acute progression ceases, thyroid hormone levels may return to normal. This may imply that thyroid hormone supplements could improve the prognosis of patients with secondary hypothyroidism. Previous clinical studies have examined the effect of thyroid HRT on patients undergoing cardiac surgery; patients with malnutrition, heart failure, or acute renal failure; and premature infants with acute respiratory distress syndrome. Most of these past studies found no significant positive effects on prognosis, and no harmful effects either. Some smaller studies have demonstrated potential promise for the use of HRT; for example, one study showed that T3 supplementation in patients undergoing cardiac surgery could lead to less need for inotropic support and better hemodynamic parameters. There are no reports of thyroid HRT improving the prognosis of neurocritical patients with secondary hypothyroidism.

The application of hormone replacement therapy in the treatment of neurocritical patients with secondary hypothyroidism remains controversial.

This study aims to explore the safety and effectiveness of thyroid hormone replacement therapy in patients with spontaneous intracerebral hemorrhage and concomitant secondary hypothyroidism.

Conditions

Intracerebral Hemorrhage; Low T3 Syndrome; Neurocritical Care; Hormone Replacement Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Thyroid hormone replacement therapy

Upon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing \<75kg) or 150μg qd (for individuals weighing \>75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days.

Group Type: EXPERIMENTAL

Euthyrox

Intervention Type: DRUG

Upon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing \<75kg) or 150μg qd (for individuals weighing \>75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days.

Non-thyroid hormone replacement therapy

Patients will not receive the oral levothyroxine sodium tablets.

Group Type: SHAM_COMPARATOR

Euthyrox

Intervention Type: DRUG

Patient will not receive the oral levothyroxine sodium tablets.

Interventions

Euthyrox

Upon discovering low T3 or low T4 levels, administer oral levothyroxine sodium tablets daily. If accompanied by a decrease in TSH, the regimen is 100μg qd (for individuals weighing \<75kg) or 150μg qd (for individuals weighing \>75kg). If not accompanied by a decrease in TSH, the regimen is 50μg qd. However, if thyroid function does not significantly improve within 3 days of medication, the regimen is adjusted to 100μg qd. Treatment should continue until transfer out of the NICU or discharge, with a minimum duration of 7 days.

Intervention Type: DRUG

Euthyrox

Patient will not receive the oral levothyroxine sodium tablets.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Admittance of neurocritical patients to the Neurological Intensive Care Unit (NICU) with a Glasgow Coma Scale (GCS) score of 3-8 and supratentorial hematoma volume >30 ml. The disease is limited to spontaneous intracerebral hemorrhage (supratentorial brain parenchyma, with or without hematoma rupture into the ventricle).

2. Age: 18-80 years old.

3. Onset within 24 hours.

4. Free T3 < 1.80 pg/ml or free T4 < 0.81 ng/dl within 7 days of onset, with or without TSH < 0.38 μIU/ml. (Specifically according to the critical values of different center laboratories' abnormal ranges).

5. Emergency head CT scan completed within 24 hours of onset.

Exclusion Criteria

1. Organic thyroid lesions (subacute thyroiditis, chronic thyroiditis, post-thyroidectomy, thyroid radiation, hyperthyroidism), history of thyroid hormone oral replacement therapy within the past month.

2. Sella region lesions.

3. Baseline CT indicates irreversible brain herniation, expected survival period <30 days.

4. Severe systemic multiple injuries outside the nervous system.

5. Pregnant women.

6. Acute or chronic heart failure, arrhythmias, myocardial disease.

7. Only TSH levels decrease while free T3 and free T4 levels remain normal.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Junji

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking union medical college hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Junji Wei

Role: CONTACT

weijunji@pumch.cn

15801056698 ext. 86

Facility Contacts

Junji Wei

Role: primary

weijunji@pumch.cn

+8615801056698

Other Identifiers

PUMCH-20240311

Identifier Type: -

Identifier Source: org_study_id