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Trial registered on ANZCTR


Registration number
ACTRN12619001707156
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
4/12/2019
Date last updated
4/12/2019
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Intravenous Sodium bicarbonate replacement in patients with toluene intoxication.
Scientific title
Intravenous Sodium bicarbonate replacement and metabolic acidosis resolution in patients with acute toluene intoxication.
Secondary ID [1] 299295 0
Nil secondary ID.
Universal Trial Number (UTN)
U1111-1240-3378.
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Toluene Intoxication. 314422 0
Condition category
Condition code
Renal and Urogenital 312765 312765 0 0
Kidney disease
Injuries and Accidents 313351 313351 0 0
Poisoning

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315569 0
Treatment: Drugs
Comparator / control treatment
Group B were given 10 mL saline solution as 4 hours infusion for up to 3 doses if the pH is <7.30. All patients underwent serum electrolytes and venous or arterial blood gases every 4 hours since admission for up to 3 samples.
Control group
Placebo

Outcomes
Primary outcome [1] 321389 0
To evaluate the time, in hours, of metabolic acidosis resolution assessed by blood pH >7.3.
Timepoint [1] 321389 0
48 hours post-commencement of the treatment.
Secondary outcome [1] 374845 0
To compare the mean metabolic acidosis resolution time, in hours, assessed by blood gas pH>7.3, between groups.
Timepoint [1] 374845 0
48 hours post-commencement of the treatment.
Secondary outcome [2] 374846 0
To compare the mean hospitalization days assessed by clinical charts records between groups.
Timepoint [2] 374846 0
48 hours post-commencement of the treatment.
Secondary outcome [3] 374847 0
To comparte the amount of potassium administered assessed by clinical charts records, in mEq, between groups.
Timepoint [3] 374847 0
48 hours post-commencement of the treatment.
Secondary outcome [4] 374848 0
To compare the amount of fluid administered assessed by clinical charts records, in mL, between groups.
Timepoint [4] 374848 0
48 hours post-commencement of the treatment.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cardio respiratory arrest, history (6 months) of heart failure diagnosis or chronic kidney disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software generated by radioactive decay.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The calculated sample was determined by the ratio difference formula resulting in 18 patients, taking as reference a power of 80% and alpha of 5. The data will be reported as mean and standard deviation or median and range, accordingly to data normality distribution. To compare the standard deviation, a Fischer test will be applied in the correlation of coefficients. Confidence intervals of 95% will be used. Evaluation of qualitative variables through Chi square (tables 2x2 or 2x3) where the difference was established when the p was less than or equal to 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/01/2020
Actual
Date of last participant enrolment
Anticipated
28/02/2020
Actual
Date of last data collection
Anticipated
13/03/2020
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 21872 0
Mexico
State/province [1] 21872 0
Nuevo León

Funding & Sponsors
Funding source category [1] 303819 0
Hospital
Name [1] 303819 0
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Country [1] 303819 0
Mexico
Primary sponsor type
Hospital
Name
Hospital Universitario, Dr. José E. González, Universidad Autónoma de Nuevo León
Address
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country
Mexico
Secondary sponsor category [1] 303944 0
None
Name [1] 303944 0
Address [1] 303944 0
Country [1] 303944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304333 0
Hospital Universitario Ethics Committee, Universidad Autónoma de Nuevo León
Ethics committee address [1] 304333 0
Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México.
Ethics committee country [1] 304333 0
Mexico
Date submitted for ethics approval [1] 304333 0
05/06/2018
Approval date [1] 304333 0
08/07/2019
Ethics approval number [1] 304333 0
MI-18-003

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96578 0
Dr Héctor Raúl Ibarra Sifuentes
Address 96578 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 96578 0
Mexico
Phone 96578 0
+52 81 8389 1111
Fax 96578 0
Email 96578 0
[email protected]
Contact person for public queries
Name 96579 0
Héctor Raúl Ibarra Sifuentes
Address 96579 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 96579 0
Mexico
Phone 96579 0
+52 81 8389 1111
Fax 96579 0
Email 96579 0
[email protected]
Contact person for scientific queries
Name 96580 0
Héctor Raúl Ibarra Sifuentes
Address 96580 0
Hospital Universitario, "Dr Jose E. Gonzalez", Facultad de Medicina, Universidad Autónoma de Nuevo Leon, Av. Madero and Av. Gonzalitos n/n, Mitras Centro, Monterrey, Nuevo León, México, postal code 64460.
Country 96580 0
Mexico
Phone 96580 0
+52 81 8389 1111
Fax 96580 0
Email 96580 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Time of mean metabolic resolution in the intervention and control group.
When will data be available (start and end dates)?
From April 30th 2020 to March 30th 2021.
Available to whom?
Researchers who contact the corresponding author.
Available for what types of analyses?
Statistical.
How or where can data be obtained?
Access subject to approvals by Principal Investigator contacted at [email protected] or [email protected].


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.