2025-524175-23-00招募中4 期
Impact of Early Thyroid Hormone Replacement on Kidney Function and Health-Related Quality of Life in Patients at Risk of Postoperative Hypothyroidism after Hemithyroidectomy: A Randomised Controlled Trial
Region Midtjylland2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年2月2日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change eGFR from baseline to 3 months postoperatively, measured in mL/min/1.73m² using standard laboratory methods.
研究概览
简要总结
To evaluate whether postoperative treatment with LT4 leads to an improvement in kidney function - measured as change in eGFR - three months after HT, compared to standard care without LT4
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients referred for a first hemithyroidectomy
- •TSH ≥2 mUI/L.
- •eGFR > 30 mL/min/1.73m
- •Age 18 years or above
- •Ability to understand the study information and provide written informed consent.
- •Able and willing to comply with study procedures and attend scheduled visits.
排除标准
- •Previous thyroid operation
- •Initiated treatment with either ACE inhibitors, ARB or SGLT2 after surgery.
- •Inability to understand Danish or provide informed consent.
- •Participation in another interventional study that may interfere with outcomes.
- •Planned total thyroidectomy or completion thyroidectomy during follow-up
- •Treatment with Thycapzole or similar medication with direct effect on thyroid hormones.
- •Concomitant operation for primary hyperparathyroidism (PHPT).
- •Pregnancy or plans of pregnancy in the postoperative period.
- •Cancer treatment within the last three years.
- •Use of narcotics or alcohol abuse.
- •Severe other illness (psychiatric disorder, kidney disease with GFR < 30 etc.).
- •Severe cardio-vascular disease (atrial fibrillation, heart failure etc.).
研究组 & 干预措施
LEVOTHYROXINE SODIUM , LEVOTHYROXINE, LEVOTHYROXINE
Test
干预措施: LEVOTHYROXINE SODIUM (Drug)
LEVOTHYROXINE SODIUM , LEVOTHYROXINE, LEVOTHYROXINE
Test
干预措施: LEVOTHYROXINE (Drug)
结局指标
主要结局
Change eGFR from baseline to 3 months postoperatively, measured in mL/min/1.73m² using standard laboratory methods.
Change eGFR from baseline to 3 months postoperatively, measured in mL/min/1.73m² using standard laboratory methods.
次要结局
- Change in body weight (kg) and BMI (kg/m²) from baseline to 3 months and 6 months.
- In control group participants who initiate THRT at 3 months due to elevated TSH (>1.5 mIU/L), follow-up changes in eGFR and HRQoL at 6 months.
- Serum levels of TSH, T4, and T3 at 3 months postoperatively.
- ThyPRO-39 composite score changes from baseline to 3 and 6 months postoperatively.
研究者
Mathilde Lykke Seekjær
Scientific
Region Midtjylland
研究点 (2)
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