Clinical trial NCT06622525: Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke
Official title: Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heat Stroke
Acute Kidney Injury
Acute Kidney Injury Due to Hypovolaemia
Lead sponsor: Hospital General de Mexicali
Sponsor class: OTHER
Collaborators: name: Universidad Autonoma de Baja California
First posted: 2024-10-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: The use of sodium bicarbonate reduces the need for renal replacement therapy
timeFrame: From enrollment until discharge or death.
Secondary outcomes:
measure: Creatinine levels
timeFrame: From enrollment until discharge or death.
measure: Mortality rate
timeFrame: From enrollment until discharge or death.
measure: Mortality rate of patients diagnosed with heat stroke who were administered bicarbonate compared to those who did not receive bicarbonate.
timeFrame: From enrollment until discharge or death.
measure: Potassium levels in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
timeFrame: From enrollment until discharge or death.
measure: Difference in the length of hospital stay for patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
timeFrame: From enrollment until discharge or death.
measure: Difference in the requirements for vasopressors in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
timeFrame: From enrollment until discharge or death.
measure: Use of mechanical ventilation in patients diagnosed with heat stroke
timeFrame: From enrollment until discharge or death.
Other outcomes:
Locations:
city: Mexicali
country: Mexico
facility: Hospital General de Mexicali
state: Baja California
Study officials:
affiliation: Hospital General de Mexicali
name: Hiram J Jaramillo Ramirez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouchama A, Knochel JP. Heat stroke. N Engl J Med. 2002 Jun 20;346(25):1978-88. doi: 10.1056/NEJMra011089. No abstract available.