Use of Sodium Bicarbonate As Prophylaxis for Kidney Damage in Patients with Heatstroke

NCT06622525 | Recruiting DMC

• 1 other identifier: HGMexicali
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stroke; Acute Kidney Injury; Acute Kidney Injury Due to Hypovolaemia

Outcome Measures

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.

  From enrollment until discharge or death.

Secondary Outcomes (7)

• Creatinine levels

  From enrollment until discharge or death.

• Mortality rate

  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.

  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.

  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.

  From enrollment until discharge or death.

Study Arms (2)

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.

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.

Other: No intervention

Interventions

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.

Intervention Group

No intervention OTHER

The usual management for heat stroke will be given to this group

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Lack of serum creatinine levels at the time of admission to the protocol.

Sponsors & Collaborators

• Hospital General de Mexicali: lead
• Universidad Autonoma de Baja California: collaborator

Study Sites (1)

Hospital General de Mexicali

Mexicali, Estado de Baja California, 21000, Mexico

RECRUITING

Related Publications (1)

• Bouchama A, Knochel JP. Heat stroke. N Engl J Med. 2002 Jun 20;346(25):1978-88. doi: 10.1056/NEJMra011089. No abstract available.

  PMID: 12075060 BACKGROUND

MeSH Terms

Conditions

Heat Stroke; Acute Kidney Injury

Interventions

Sodium Bicarbonate; Control Groups

Condition Hierarchy (Ancestors)

Heat Stress Disorders; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hiram J Jaramillo Ramirez, MD

  Hospital General de Mexicali

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, open-label clinical trial at the General Hospital of Mexicali; central tendency measures will be obtained for variables.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: October 2, 2024
• Study Start: May 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)