NCT06353555

Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage

Recruiting now NA Last updated 9 April 2024

What this trial tests

NA trial testing Euthyrox in Intracerebral Hemorrhage in 100 participants. Currently enrolling.

Timeline

11 October 2023

Primary endpoint
1 June 2025

31 December 2025

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	11 October 2023
Primary completion	1 June 2025
Estimated completion	31 December 2025
Sites	1 location across China

Drugs / interventions tested

• Euthyrox — full drug profile →
• Euthyrox — full drug profile →

Conditions studied

• Intracerebral Hemorrhage — all drugs for Intracerebral Hemorrhage →
• Low T3 Syndrome — all drugs for Low T3 Syndrome →
• Neurocritical Care — all drugs for Neurocritical Care →
• Hormone Replacement Therapy — all drugs for Hormone Replacement Therapy →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 80, any sex, with Intracerebral Hemorrhage or Low T3 Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.