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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Heat Stroke; Acute Kidney Injury Due to Hypovolaemia
• Intervention / Treatment: Drug: Sodium bicarbonate; Other: No intervention

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 Type: Interventional
• Enrollment (Estimated): 1
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joaquin Cordova Erberk, MD; Phone Number: +52 653 132 0309; Email: joaquincerberk@gmail.com
• Study Contact Backup: Name: Hiram J Jaramillo Ramirez, MD; Phone Number: +52 653 132 0309; Email: grupoinvestigacionmedica@gmail.com

Study Locations

• Mexico
  • Baja California
    • Mexicali, Baja California, Mexico, 21000
      • Recruiting
      • Hospital General de Mexicali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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 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.
Active Comparator: Control Group; This group will be manage with the usual care that is given to patients with heat stroke in this hospital.	Other: No intervention; The usual management for heat stroke will be given to this group; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: Hospital General de Mexicali
• Collaborators: Universidad Autonoma de Baja California
• Investigators: Principal Investigator: Hiram J Jaramillo Ramirez, MD, Hospital General de Mexicali

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 30, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Heat Stress Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury; Hypovolemia; Heat Stroke
• Other Study ID Numbers: HGMexicali

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There will be no disclousure of the patients information to thrid party members.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No