Investigating the effect of theophylline on vancomycin-induced nephrotoxicity in children aged one month to 18 years with severe infection compared to vancomycin alone.
Determining the prophylactic effect of theophylline on vancomycin-induced nephrotoxicity
Design
A clinical trial with a control group, parallel groups, blinded outcome assessment, randomized on 34 patients
Settings and conduct
In this study, which is a clinical trial and is performed in Sabzevar Heshmatieh Hospital, patients who are treated with vancomycin due to severe systemic infection including meningitis and septicemia will be selected.The patients will be one month to 18 year old. 34 patients are divided into two groups of 17 people. The permutation block method is used to allocate the samples. The method of blindness is single-blinding so that the evaluators do not know how to allocate the drug.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients with systemic infection treated with vancomycin
Complete the informed consent form
Age one month to 18 years
Exclusion criteria:
Patients who are discharged from the hospital before three days.
Patients with unpredictable complications.
Patients with drug side effects.
Intervention groups
The control group treated with vancomycin and the intervention group received theophylline every 12 hours for three days in addition to vancomycin.
Investigating the effect of theophylline on vancomycin-induced nephrotoxicity in children aged one month to 18 years with severe infection compared to vancomycin alone.
Public title
The prophylactic effect of theophylline on vancomycin-induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with systemic infection treated with vancomycin
Patients one month to 18 years
Complete the informed consent form
Exclusion criteria:
Patients who are discharged from the hospital before three days.
Patients with unpredictable complications.
Patients with drug side effects.
Age
From 1 month old to 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all children with severe infection, including meningitis and septicemia, who are treated with vancomycin are included.
In this method, we have two treatment groups, where T is considered as the group receiving theophylline and vancomycin, and C is considered as the group receiving vancomycin. Including blocks of four, we will have six modes that we use in the form of six cards with a replacement for random allocation. These six modes are as follows.
TTCC, TCTC, CTTC, CTCT, TCCT, CCTT
For a sample size of 34 to 9 times, we use the above cards with replacement.
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding is single-blinding.
The researcher knows how to allocate drugs to the samples.
The laboratory expert does not know how to allocate the drugs to the samples.
The evaluator of laboratory results, is a person who is not aware of the treatment allocation.
The outcome is evaluated objectively, so there is no necessity to blind the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
No. 196, Al-ahmad sq.,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617697481
Approval date
2022-01-02, 1400/10/12
Ethics committee reference number
IR.MEDSAB.REC.1400.138
Health conditions studied
1
Description of health condition studied
nephrotoxicity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The percentage of people treated with vancomycin who develop microalbuminuria
Timepoint
Measurement of microalbuminuria at the beginning of the study and 72 hours after starting treatment with vancomycin
Method of measurement
Measurement of microalbuminuria in urine sample.The range is 30-300 mg per 24 hours.
2
Description
The percentage of people treated with vancomycin who experience an increase in urea and creatinineCommunity Verified icon
Timepoint
Measurement of urea and creatinine at the beginning of the study and 72 hours after starting vancomycin treatment
Method of measurement
Measurement of urea and creatinine in serum samples.Depending on the patients age, urea 20-30 mg/dL and creatinine 0.4-1 mg/dL.
Secondary outcomes
1
Description
Patient weight change
Timepoint
before treatment & after three days from the start of treatment
Method of measurement
Measuring the patient's weight in kilograms with a digital scale
Intervention groups
1
Description
Intervention group:Patients are treated with vancomycin and theophylline. Vancomycin is prescribed at a dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.) Depending on which form of theophylline the child is able to take, syrup or tablets are chosen. Theophylline is prescribed daily at a dose of 5 mg/kg and lasts for three days.(Theochal-G syrup made by Alborz Drug Company or theophylline tablet E.R. 200 made by Razak Laboratory Company.)
Category
Prevention
2
Description
Control group:pattients are only treated with vancomycin. Vancomycin is prescribed with dose of 15 mg/kg every eight hours from the first day of hospitalization. The duration of treatment is 7-10 days.(Vancomycin 500 vial manufactured by Dana Company under the brand name Vancomax.)