Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06622525

Use of Sodium Bicarbonate as Prophylaxis for Kidney Damage in Patients With Heatstroke

Led by Hospital General de Mexicali · Updated on 2024-10-02

1

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

H

Hospital General de Mexicali

Lead Sponsor

U

Universidad Autonoma de Baja California

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to prevent kidney damage and the need for renal replacement therapy in patients who develop rhabdomyolysis due to heatstroke. It builds on earlier studies where bicarbonate infusion lowered the risk of kidney failure in similar conditions. The study is conducted at the General Hospital of Mexicali, focusing on patients admitted during the summer months when heatstroke is common. Participants will be randomly assigned to one of two groups. One group receives an infusion of 100 mEq sodium bicarbonate diluted in one liter of saline at a rate of 100 ml per hour, aiming to keep urine pH above 6.5. The other group receives the usual care provided to heatstroke patients at the hospital. The intervention begins upon enrollment and continues until discharge or death. During the study, researchers will monitor outcomes like the need for renal replacement therapy, kidney function through creatinine levels, mortality rates, potassium levels, length of hospital stay, use of vasopressors, and mechanical ventilation requirements. These measures will be tracked from enrollment until discharge or death to evaluate the impact of sodium bicarbonate infusion compared to standard treatment.

CONDITIONS

Brief Title

Use of Sodium Bicarbonate as Prophylaxis for Kidney Damage in Patients With Heatstroke

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted to the General Hospital of Mexicali with a diagnosis of heat stroke
  • Exposure to heat with body temperature at admission greater than 40 degrees Celsius
  • Creatine phosphokinase (CPK) level greater than 1000 U/L
  • Provided informed consent from the patient or legally responsible adult
Not Eligible

You will not qualify if you...

  • Heat stroke diagnosis excluded during evaluation
  • Missing serum creatinine levels at admission to the protocol

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - From enrollment until discharge or death

Participants receive either sodium bicarbonate infusion or usual care to prevent kidney damage caused by heatstroke.

Trial Site Locations

Total: 1 location

1

Hospital General de Mexicali

Mexicali, Estado de Baja California, Mexico, 21000

Actively Recruiting

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Research Team

J

Joaquin Cordova Erberk, MD

H

Hiram J Jaramillo Ramirez, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial