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临床试验/CTRI/2024/04/065288
CTRI/2024/04/065288尚未招募不适用

Prospective observational study of effects of cardiopulmonary bypass in cardiac surgery on thyroid function tests in euthyroid patients and in patients on thyroid medications

Dr Sanjeeta Umbarkar1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Change in free t3, free t4 and tsh levels in the preoperative and postoperative period

研究概览

简要总结

Cardiopulmonary bypass used in various cardiac surgeries has effects on various organ systems. This study intends to observe effects of cardiopulmonary bypass on thyroid function tests. Patients posted for cardiac surgery with cardiopulmonary bypass will be recruited in the study. After thorough pre-operative assessment, their pre-operative Thyroid function values (Serum Free T3, Serum Free T4 and Serum TSH) will be recorded. Presence or absence of any previous thyroid disorder will be recorded along with thyroid medications. Surgery will be conducted under standard protocol. Total cardiopulmonary bypass duration, aortic cross clamp duration, temperature and perfusion pressure during bypass duration will be recorded. Thyroid functions tests (Serum Free T3, Serum Free T4 and Serum TSH) will be repeated 24 hours after surgery. Difference in Thyroid function will be analyzed for statistical significance. At the same time, correlation of the difference in Thyroid function tests with post operative ICU course will be observed and analyzed for statistical significance.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing cardiac surgery with cardiopulmonary bypass.

排除标准

  • Non cardiac surgery
  • Cardiac surgery without cardiopulmonary bypass
  • Any other previous endocrine abnormality preoperatively
  • Emergency cardiac surgery with or without cardiopulmonary bypass.

结局指标

主要结局

Change in free t3, free t4 and tsh levels in the preoperative and postoperative period

时间窗: Before surgery | 24 hours after surgery

次要结局

  • 1. Correlation of changes in thyroid function with aortic cross clamp and cp bypass duration(2. Postoperative hemodynamics)

研究者

发起方
Dr Sanjeeta Umbarkar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sanjeeta Umbarkar

Seth G. S. Medical College and K. E. M Hospital

研究点 (1)

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