Phase 3
N=70
Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery
Cardiac Surgery Intensive Care Treatment · Delayed Recovery From Anaesthesia · Euthyroid Sick Syndrome · Cardiac Surgery Requiring Cardiopulmonary Bypass
Bottom Line
View on ClinicalTrials.gov: NCT06660823 ↗Enrolled (actual)
70
Serious AEs
20.0%
Results posted
Aug 2025
Primary outcome: Primary: Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ) — 6.65; 2.69 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- L-thyroxine (Drug); Placebo Oral Tablet (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Ain Shams University
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ) |
6.65; 2.69 | — |
| SECONDARY Total Duration of Mechanical Ventilation |
130.40; 142.14 | — |
| SECONDARY Duration of Intensive Care Unit (ICU) Stay |
9.03; 7.51 | — |
| SECONDARY Total Hospital Stay Stay. |
13.06; 10.29 | — |
| SECONDARY Average Inotropic Support Infusion Rate in ICU |
79.60; 135.86; 83.70; 137.93 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to ICU Discharge |
-6.15; -19.14 | — |
| SECONDARY Number of Participants With New-onset Supraventricular Arrhythmia |
1; 13 | — |
Summary
Research indicates that hypothyroidism decreases heart contractility, reduces stroke volume and rate, affects the vascular endothelium, and increases the risk of atherosclerosis, systemic vascular resistance, hypertension, atherogenic lipid profile, and coagulation abnormality .
Hypothyroidism was reported to be strongly related to cardiovascular disease, respiratory complications, neurological complications, and a significant difference in ventilator weaning time.
Once subclinical hypothyroidism patients are treated with levothyroxine, their physical fitness measured by a 6-minute walk is significantly improved, also showed that levothyroxine treatment can optimize the treatment of heart failure with preserved functions (HFpEF) and heart failure with reduced functions (HFrEF) patients with systolic left ventricular dysfunction and sub clinical hypothyroidism (SCH).
The primary aim of this study is to investigate the effect of supplementation of oral levothyroxine in delayed recovery patients post cardiac surgery.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT06660823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.