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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heat Stroke Acute Kidney Injury Acute Kidney Injury Due to Hypovolaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Sodium bicarbonate

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

The usual management for heat stroke will be given to this group

Interventions

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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.

Intervention Type DRUG

No intervention

The usual management for heat stroke will be given to this group

Intervention Type OTHER

Other Intervention Names

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Control Group

Eligibility Criteria

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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.