Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353555
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-11
Brief Title:
Efficacy of Thyroid Hormone Replacement for Secondary Hypothyroidism Following Intracerebral Hemorrhage
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Study on the Efficacy of Thyroid Hormone Replacement Therapy for Secondary Hypothyroidism Following Intracerebral Hemorrhage
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 T3T4 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
Patients with severe neurological diseases often experience more complications and exhibit higher mortality rates and many studies have provided evidence for a low T3T4 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None