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Intravenous Sodium bicarbonate replacement in patients with toluene intoxication.

Intravenous Sodium bicarbonate replacement and metabolic acidosis resolution in patients with acute toluene intoxication.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001707156
Enrollment
18
Registered
2019-12-04
Start date
2020-01-15
Completion date
2020-02-28
Last updated
2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Toluene is widely available in over-the-counter products and is most commonly used abuse substance as an inhaled drug in developing countries. The clinical picture of these patients is hypokalemic paralysis and metabolic acidosis. The treatment for this intoxication is not studied, and is expert opinion based on hydration and intravenous potassium replacement; however, the treatment of acidosis is not established. Authors designed a randomized controlled clinical trial, in patients with acute toluene intoxication, who are admitted at the emergency department. Inclusion criteria are patients greater than or equal to 18 years with toluene poisoning clinical diagnosis, recently inhaled toluene history (less than or equal to 7 days), pH less than or equal to 7.25, and serum potassium between 1.1-5.5 mmol/L. Patients will be randomized 1:1 to the administration on Group A, sodium bicarbonate and group B, No sodium bicarbonate. Group A will receive 100 mmol sodium bicarbonate as 4 hours infusion for up to 3 doses if the pH is less than 7.30. In group B, normal saline solution will be administered. Serum electrolytes and venous or arterial blood gases every 4 hours since admission for up to 3 samples will be analyzed. The main outcome is to evaluate the time of metabolic acidosis resolution measured in hours.

Interventions

Group A were given 100 mmol sodium bicarbonate as 4 hours infusion for up to 3 doses if the blood pH is <7.30. All patients are going to measure serum electrolytes and venous or arterial blood gases every 4 hours since admission for up to 3 samples. The strategies used to assess or monitor fidelity to the intervention are audit of nurse notes and electronic clinical charts.

Sponsors

Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria are patients more or equal to 18 years, toluene poisoning clinical diagnosis, recently inhaled toluene history (<7 days), pH less or equal to 7.25, and serum potassium between 1.1-5.5 mmol/L.

Exclusion criteria

Patients with cardio respiratory arrest, history (6 months) of heart failure diagnosis or chronic kidney disease.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026