Role of Levothyroxine Supplementation in Delayed Recovery Following Cardiac Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ)
研究概览
简要总结
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.
详细描述
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. Severe thyroid dysfunction is related to muscle relaxation and lead to respiratory muscle depression and disturbed conscious level.Surgical stress of cardiac surgery might be followed by a prolonged recovery process and cardiac dysfunction .
The exact physiology of thyroid disease and the relationship with post cardiac surgery remain unclear. Thus far, large-scale clinical statistical analysis evidence on the complication rate and long-term mortality is lacking. Current important prognostic assessment tools such as EuroSCORE II , and Society of Thoracic Surgeons (STS) score do not include thyroid function assessment, even though it has a significant impact on the metabolic, cardiovascular, and circulation system.
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 heart is a major target of thyroid hormones, with maintenance of euthyroid hormone balance critical for proper function. Moreover, thyroid hormones have been shown a vital role in cardiac repair after injury beyond their roles in development and metabolism homeostasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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)
排除标准
- •• 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.
研究组 & 干预措施
Group A (Study group)
group A will receive levothyroxine via Ryle, dose of 25 to 50 ug/ day according to BMI
干预措施: L-thyroxine (Drug)
Group B (Control)
group B will receive placebo in form of inert starch tablet
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in Glasgow Coma Scale (GCS) From Intervention Initiation to ICU Discharge (Δ)
时间窗: From intervention initiation (48 hours postoperatively) to ICU discharge, up to 1 month postoperatively. (i.e., within 28 days after baseline).
The Glasgow Coma Scale (GCS) assesses conscious level through three components: Eye response (scored 1-4): 4: Opens eyes spontaneously 3: Opens eyes to verbal command 2: Opens eyes to pain 1: No eye opening Verbal response (scored 1-5): 5: Oriented and converses 4: Confused 3: Inappropriate words 2: Incomprehensible sounds 1: No verbal response Motor response (scored 1-6): 6: Obeys commands 5: Localizes to pain 4: Withdraws from pain 3: Abnormal flexion (decorticate) 2: Abnormal extension (decerebrate) 1: No motor response The total GCS score ranges from 3 (worst) to 15 (best), with higher scores indicating better neurological function. The primary outcome is the change in total GCS score from baseline (48 hours postoperatively, before intervention) to ICU discharge.
次要结局
- Total Duration of Mechanical Ventilation(From surgery completion until extubation (assessed for ≤30 days postoperatively).)
- Duration of Intensive Care Unit (ICU) Stay(From ICU admission until discharge/death (assessed for ≤30 days postoperatively).)
- Total Hospital Stay Stay.(30 days)
- Average Inotropic Support Infusion Rate in ICU(From ICU admission until discontinuation of inotropic support or ICU discharge (assessed daily for ≤30 days).)
- Number of Participants With New-onset Supraventricular Arrhythmia(From ICU admission until discharge or death (≤30 days postoperatively).)
- Change in Left Ventricular Ejection Fraction (LVEF) From Baseline to ICU Discharge(Preoperative assessment: Within 24 hours before surgery Postoperative assessment: At ICU discharge (≤30 days postoperatively))
研究者
sarah hamdy
Lecturer of Anesthesia,ICU and pain management
Ain Shams University