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临床试验/NCT06622525
NCT06622525招募中不适用

Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke

Hospital General de Mexicali1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1
试验地点
1
主要终点
The use of sodium bicarbonate reduces the need for renal replacement therapy

研究概览

简要总结

This study protocol aims to prevent the need for renal replacement therapy in patients with rhabdomyolysis secondary to heatstroke. It is based on previous studies showing that bicarbonate infusion reduces renal failure in similar contexts. The intervention will be conducted at the General Hospital of Mexicali during the summer, targeting the prevention of renal failure and reducing the necessity for renal replacement therapy.

详细描述

The present study protocol explores the possibility of preventing the need for renal replacement therapy in patients who develop rhabdomyolysis secondary to heatstroke. This is based on previous studies that have used bicarbonate infusion in the context of rhabdomyolysis secondary to compartment syndrome, finding a lower incidence of renal failure. Due to the aforementioned, we propose to carry out a similar intervention at the General Hospital of Mexicali, where there is a significant incidence of heatstroke during the summer months. The aim is to determine whether this intervention is useful in preventing the development of renal failure and the requirement for renal replacement therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to the General Hospital of Mexicali with the diagnosis of heat stroke.
  • Meeting the operational definition (exposure to heat, body temperature at admission greater than 40 degrees Celsius).
  • CPK level greater than 1000 U/L.
  • Having informed consent from the patient or the legally responsible adult.

排除标准

  • Exclusion of the heat stroke diagnosis during their evaluation.
  • Lack of serum creatinine levels at the time of admission to the protocol.

研究组 & 干预措施

Intervention Group

Experimental

This group will receive 100 mEq of sodium bicarbonate diluted in one liter of saline solution, administered at a rate of 100 ml/h, with the goal of maintaining a urinary pH greater than 6.5.

干预措施: Sodium bicarbonate (Drug)

Control Group

Active Comparator

This group will be manage with the usual care that is given to patients with heat stroke in this hospital.

干预措施: No intervention (Other)

结局指标

主要结局

The use of sodium bicarbonate reduces the need for renal replacement therapy

时间窗: From enrollment until discharge or death.

Determine if the use of sodium bicarbonate as a prophylactic measure reduces the need for renal replacement therapy in patients with heat stroke-associated rhabdomyolysis.

次要结局

  • Potassium levels in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.(From enrollment until discharge or death.)
  • Creatinine levels(From enrollment until discharge or death.)
  • Mortality rate(From enrollment until discharge or death.)
  • Mortality rate of patients diagnosed with heat stroke who were administered bicarbonate compared to those who did not receive bicarbonate.(From enrollment until discharge or death.)
  • Difference in the length of hospital stay for patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.(From enrollment until discharge or death.)
  • Difference in the requirements for vasopressors in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.(From enrollment until discharge or death.)
  • Use of mechanical ventilation in patients diagnosed with heat stroke(From enrollment until discharge or death.)

研究者

发起方
Hospital General de Mexicali
申办方类型
Other
责任方
Sponsor

研究点 (1)

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