Use of Sodium Bicarbonate as Prophylaxis for Kidney Damage in Patients With Heatstroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital General de Mexicali
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Exclusion of the heat stroke diagnosis during their evaluation.
Lack of serum creatinine levels at the time of admission to the protocol.
Trial design
Design model
Parallel
Treatments tested in this trial
Sodium bicarbonate
DrugThis 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.
No intervention
Other interventionThe usual management for heat stroke will be given to this group
Treatment groups
1 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The use of sodium bicarbonate reduces the need for renal replacement therapy
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.
Time frame
From enrollment until discharge or death.Secondary outcomes
1
Creatinine levels
Describe the creatinine levels of patients diagnosed with heat stroke at the General Hospital of Mexicali.
Time frame
From enrollment until discharge or death.2
Mortality rate
Determine the mortality rate of patients admitted with the diagnosis of heat stroke at the General Hospital of Mexicali.
Time frame
From enrollment until discharge or death.3
Mortality rate of patients diagnosed with heat stroke who were administered bicarbonate compared to those who did not receive bicarbonate.
Determine the mortality rate of patients diagnosed with heat stroke who were administered bicarbonate compared to those who did not receive bicarbonate.
Time frame
From enrollment until discharge or death.4
Potassium levels in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
Describe the potassium levels in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
Time frame
From enrollment until discharge or death.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hospital General de Mexicali
Lead sponsor
Universidad Autonoma de Baja California
Collaborator
Source ClinicalTrials.gov