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

Not Applicable

Recruiting

• Conditions: Heat Stroke; Acute Kidney Injury; Acute Kidney Injury Due to Hypovolaemia
• Interventions: Drug: Sodium bicarbonate; Other: No intervention

• Registration Number: NCT06622525
• Lead Sponsor: Hospital General de Mexicali

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.

Study Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-09-30
• Last Update Submitted: 2024-09-30
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Sodium bicarbonate	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.
Control Group	No intervention	This group will be manage with the usual care that is given to patients with heat stroke in this hospital.

Primary Outcome Measures

Name	Time	Method
The use of sodium bicarbonate reduces the need for renal replacement therapy	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 Outcome Measures

Name	Time	Method
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.	Describe the potassium levels in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
Creatinine levels	From enrollment until discharge or death.	Describe the creatinine levels of patients diagnosed with heat stroke at the General Hospital of Mexicali.
Mortality rate	From enrollment until discharge or death.	Determine the mortality rate of patients admitted with the diagnosis of heat stroke at the General Hospital of Mexicali.
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.	Determine the mortality rate of patients diagnosed with heat stroke who were administered bicarbonate compared to those who did not receive bicarbonate.
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.	Determine if there is a difference in the length of hospital stay for patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
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.	Establish if there is a difference in the requirements for vasopressors in patients
Use of mechanical ventilation in patients diagnosed with heat stroke	From enrollment until discharge or death.	Establish if there is a difference in the use of mechanical ventilation in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.

Trial Locations

Locations (1)

Hospital General de Mexicali; 🇲🇽 Mexicali, Baja California, Mexico