Heat StrokeNCT06622525
Use of Sodium Bicarbonate as Prophylaxis for Kidney Damage in Patients With Heatstroke
A study testing Sodium bicarbonate in people with Heat Stroke and Acute Kidney Injury, run by Hospital General de Mexicali at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heat Stroke, Acute Kidney Injury, Acute Kidney Injury Due to Hypovolaemia
- What is being tested?
- Sodium bicarbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2024to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion of the heat stroke diagnosis during their evaluation.
- Lack of serum creatinine levels at the time of admission to the protocol.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Mexicali
Mexicali, Estado de Baja California, 21000
About this study
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.
Read the 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.
- Being tested
- Sodium bicarbonate, No intervention
- Medical subject headings
- Heat Stroke, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
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.
No interventionOther
Also called Control Group
The usual management for heat stroke will be given to this group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sodium bicarbonate |
| Control Group | Active comparator | This group will be manage with the usual care that is given to patients with heat stroke in this hospital. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until discharge or death.
Secondary outcomes (7)
Creatinine levels
Describe the creatinine levels of patients diagnosed with heat stroke at the General Hospital of Mexicali.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From enrollment until discharge or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 May 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heat StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexicali
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Autonoma de Baja California
- Responsible party
- Sponsor
- Investigators
- Hiram J Jaramillo Ramirez, MD, Principal investigator, Hospital General de Mexicali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622525
- Sponsor's protocol ID
- HGMexicali
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no disclousure of the patients information to thrid party members.
Publications
Bouchama A, Knochel JP. Heat stroke. N Engl J Med. 2002 Jun 20;346(25):1978-88. doi: 10.1056/NEJMra011089. No abstract available.
PubMed 12075060
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sodium Bicarbonate as Prophylaxis for Kidney Damage in Patients With Heatstroke
- ClinicalTrials.gov ID
- NCT06622525
- Acronym / sponsor ID
- HGMexicali
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Hospital General de MexicaliUniversity, hospital or other
- Collaborators
- Universidad Autonoma de Baja California
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Sodium bicarbonateThis 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. |
| Control Group | Active comparator | Other: No interventionThis group will be manage with the usual care that is given to patients with heat stroke in this hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Exclusion of the heat stroke diagnosis during their evaluation.
- Lack of serum creatinine levels at the time of admission to the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateThis 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 | Intervention Group |
| No interventionAlso: Control GroupThe usual management for heat stroke will be given to this group | Other | Control Group |
Primary outcome
The use of sodium bicarbonate reduces the need for renal replacement therapy
Time frame: 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.
7 secondary outcomes
Creatinine levels
Time frame: From enrollment until discharge or death.
Mortality rate
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.
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.
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.
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.
Time frame: From enrollment until discharge or death.
Use of mechanical ventilation in patients diagnosed with heat stroke
Time frame: From enrollment until discharge or death.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Results publication: PubMed 12075060Bouchama A, Knochel JP. Heat stroke. N Engl J Med. 2002 Jun 20;346(25):1978-88. doi: 10.1056/NEJMra011089. No abstract available.
- Individual participant dataSharing planned: No. There will be no disclousure of the patients information to thrid party members.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hiram J Jaramillo Ramirez, MD principal investigator
Hospital General de Mexicali
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium bicarbonate in people with Heat Stroke and Acute Kidney Injury, run by Hospital General de Mexicali at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin Cordova Erberk, MD (+52 653 132 0309, joaquincerberk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The use of sodium bicarbonate reduces the need for renal replacement therapy (time frame: From enrollment until discharge or death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.