Acute Kidney Injury, Acute Kidney Injury Due to Hypovolaemia, Heat Stroke
Conditions
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.
Interventions
DRUGSodium 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.
OTHERNo intervention
The usual management for heat stroke will be given to this group
Sponsors
Universidad Autonoma de Baja California
Hospital General de Mexicali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Mexico
Contacts
Primary ContactJoaquin Cordova Erberk, MD
Backup ContactHiram J Jaramillo Ramirez, MD
Outcome results
None listed