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Clinical Trials/NCT06622525
NCT06622525
Recruiting
N/A

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

Hospital General de Mexicali1 site in 1 country1 target enrollmentMay 1, 2024

Overview

Phase
N/A
Intervention
Sodium bicarbonate
Conditions
Heat Stroke
Sponsor
Hospital General de Mexicali
Enrollment
1
Locations
1
Primary Endpoint
The use of sodium bicarbonate reduces the need for renal replacement therapy
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General de Mexicali
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Arms & Interventions

Intervention Group

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.

Intervention: Sodium bicarbonate

Control Group

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

Intervention: No intervention

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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.)

Study Sites (1)

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