An interventional study of Sodium bicarbonate and No intervention in Heat Stroke, Acute Kidney Injury and Acute Kidney Injury Due to Hypovolaemia, sponsored by Hospital General de Mexicali. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Hospital General de Mexicali · Not applicable, Interventional, and Prevention
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.
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.
21 studies on the registry are indexed under Heat Stroke; 10 are open to participants now.
This study's planned enrollment of 1 is below the median of 34 across 13 interventional studies indexed under Heat Stroke.
Browse Heat Stroke studies →Hospital General de Mexicali is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Sodium bicarbonate
This group will be manage with the usual care that is given to patients with heat stroke in this hospital.
Other: No intervention
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.
The usual management for heat stroke will be given to this group
Also known as: Control Group
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.
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.
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.
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.
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.
Difference in the length of hospital stay for patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
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.
Time frame: From enrollment until discharge or death.
Difference in the requirements for vasopressors in patients diagnosed with heat stroke who received bicarbonate compared to those who did not receive bicarbonate.
Establish if there is a difference in the requirements for vasopressors in patients
Time frame: From enrollment until discharge or death.
Use of mechanical ventilation in patients diagnosed with heat stroke
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.
Time frame: From enrollment until discharge or death.
Plan to share: No — There will be no disclousure of the patients information to thrid party members.
Started May 2024 (actual). Primary completion is estimated for Oct 2025, 17 months after the start.
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Studies of the drug tested here: Sodium Bicarbonate
Hospital General de Mexicali