Impact of thyroid hormone supplementation on postoperative care in patients with subclinical hypothyroidism following on-pump coronary bypass grafting surgery- A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary outcome will be the comparison of ICU stay duration between the two groups (thyroid supplementation vs. no supplementation)
研究概览
简要总结
This study investigates the impact of thyroid hormone supplementation on postoperative care for patients with subclinical hypothyroidism undergoing elective on-pump coronary artery bypass grafting (CABG) surgery. Subclinical hypothyroidism (SCH) is characterized by elevated TSH levels with normal thyroid hormone levels, which can affect cardiac function and recovery after surgery. The study aims to assess whether thyroid supplementation improves postoperative outcomes, particularly ICU stay duration, mechanical ventilation time, and the incidence of arrhythmias.
The study is a randomized controlled trial conducted at AIIMS Jodhpur, involving patients between 18 and 80 years undergoing elective CABG. Patients are divided into two groups: one group receives thyroid hormone supplementation (levothyroxine and liothyronine), while the other does not. The primary objective is to evaluate the impact of thyroid supplementation on ICU stay, with secondary objectives including assessing mechanical ventilation time, hospital stay, arrhythmias, and need for inotropic support.
The study uses a sample size of 82 patients, considering feasibility within the time constraints. Data is collected on preoperative, intraoperative, and postoperative variables, including TSH levels, inflammatory markers, and postoperative complications. Statistical analysis will be performed using multivariable logistic regression and Cox proportional hazards regression to compare the two groups.Ethically, the study will be conducted after obtaining patient consent, with the potential to update clinical practices and improve postoperative care for this group of patients. If successful, thyroid supplementation may shorten ICU stay, reduce the need for inotropes, and enhance recovery outcomes after CABG surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •1.All consenting patients 2.age of 18 to 80 years 3.undergoing elective on pump coronary bypass grafting surgery 4.TSH levels between 4.5 to 8mIU per mililitre.
排除标准
- •1.Patients of age older than 80 years or younger than 18 years 2.Patients undergoing emergency surgery or re-do CABG operation 3.Patients undergoing concomitant valve surgery along with CABG in the same operation.
- •oPatients with TSH levels greater than 8mIU/L.
结局指标
主要结局
The primary outcome will be the comparison of ICU stay duration between the two groups (thyroid supplementation vs. no supplementation)
时间窗: Compared postoperatively, at end of 1 month postoperatively, 2 months postoperatively
次要结局
- Secondary outcomes include the duration of mechanical ventilation, hospital stay, incidence of arrhythmias, need for IABP, and 30-day mortality.(Postoperative day 0,1,2 and 30)
研究者
Vikram Pal
AIIMS Jodhpur
