Effect of Levothyroxine on Recovery After Heart Surgery
Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery
PHASE3 · Ain Shams University · NCT06660823
This study is testing if taking levothyroxine can help adults aged 45 to 70 recover faster and feel better after heart surgery, especially for those with low thyroid function.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06660823 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of oral levothyroxine supplementation on patients recovering from cardiac surgery, particularly focusing on those with subclinical hypothyroidism. It aims to determine if levothyroxine can improve recovery times and overall physical fitness in patients who experience delayed recovery post-surgery. The study will involve adult patients aged 45 to 70 undergoing various types of cardiac surgeries, comparing outcomes between those receiving levothyroxine and those receiving a placebo. The research seeks to fill gaps in understanding the relationship between thyroid function and post-operative recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 70 who are undergoing elective, urgent, or emergency open heart surgeries.
Not a fit: Patients younger than 45 or older than 70, those with known hypothyroidism already on levothyroxine, or those with hyperthyroidism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery times and better overall outcomes for patients undergoing cardiac surgery.
How similar studies have performed: While there is some evidence suggesting thyroid function impacts recovery, this specific approach of using levothyroxine in post-cardiac surgery recovery is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • Age group: Adult patients from age of 45 to70 years. (Majority of our patients falls in this age group 45-70 years, below these patients are relatively young and usually do not show delayed recovery or prolonged ventilation, while above 70 years are considered frail and more vulnerable to anesthetic medications, so we preferred to exclude them) * Sex: Both sexes * Elective, urgent and emergency open heart surgeries. (Most of urgent and emergency cases are either mechanical valve thrombosis or aortic dissection patients, and are more prone to prolonged mechanical ventilation and delayed recovery compared to elective patients) Exclusion Criteria: * • Patients refuse to give informed consent. * Patient younger than 45 years old, older than 70 years old. * Off pump patients. * Patients known hypothyroidism on levothyroxine supplementation. * Patients known hyperthyroidism on Carbimazole. * Those developing any form of arrhythmia L-Thyroxine will be stopped immediately and the patient will be excluded from the study.
Where this trial is running
Cairo
- Faculty of Medicine ,Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Study coordinator: Sarah Hamdy El Ghareeb,MD Lecturer of Anesthesia,ICU and pain management, Doctorate of Anesthesia,ICU
- Email: sarahhamdy@med.asu.edu.eg
- Phone: +201012434690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Surgery Intensive Care Treatment, Delayed Recovery From Anaesthesia, Euthyroid Sick Syndrome, Cardiac Surgery Requiring Cardiopulmonary Bypass, L-Thyroxine, Delayed recovery post cardiac surgery, hypthyroidism