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| Name | Class |
|---|---|
| Universidad Autonoma de Baja California | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | 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. |
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| Control Group | Active Comparator | This group will be manage with the usual care that is given to patients with heat stroke in this hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium bicarbonate | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment until discharge or death. |
| Measure | Description | Time Frame |
|---|---|---|
| Creatinine levels | Describe the creatinine levels of patients diagnosed with heat stroke at the General Hospital of Mexicali. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joaquin Cordova Erberk, MD | Contact | +52 653 132 0309 | joaquincerberk@gmail.com | |
| Hiram J Jaramillo Ramirez, MD | Contact | +52 653 132 0309 | grupoinvestigacionmedica@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hiram J Jaramillo Ramirez, MD | Hospital General de Mexicali | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Mexicali | Recruiting | Mexicali | Estado de Baja California | 21000 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12075060 | Result | Bouchama A, Knochel JP. Heat stroke. N Engl J Med. 2002 Jun 20;346(25):1978-88. doi: 10.1056/NEJMra011089. No abstract available. |
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There will be no disclousure of the patients information to thrid party members.
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| ID | Term |
|---|---|
| D018883 | Heat Stroke |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.
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| No intervention | Other | The usual management for heat stroke will be given to this group |
|
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| 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. | 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. | 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. | 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 | 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. | From enrollment until discharge or death. |
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |