Determining the effectiveness of sequential and simultaneous administration of albumin and furosemide in edema reduction in pediatric nephrotic syndrome
Design
A parallel blinded randomized trial on 128 pediatric patients with Nephrotic Syndrome
Settings and conduct
This study is conducted in a referral teaching pediatric hospital. Hospitalized patients with edema and hypoalbuminemia are treated with therapeutic doses of albumin and furosemide. these patients are allocated by block randomization. The patient, the Research evaluator, and the Analyzer will be blind to the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 2 to 15 years old, children diagnosed with nephrotic syndrome
Intervention groups
One group received a mixture of Albumin and Furosemide simultaneously and the other group receives albumin first and then furosemide (after albumin administration).
Main outcome variables
Patient weight and Urine Sodium level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120415009475N11
Registration date:2022-02-22, 1400/12/03
Registration timing:registered_while_recruiting
Last update:2022-02-22, 1400/12/03
Update count:0
Registration date
2022-02-22, 1400/12/03
Registrant information
Name
Bahador Mirrahimi
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0118
Email address
mirrahimi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sequential versus Concurrent Albumin and Furosemide in Pediatric Nephrotic Syndrome Patients
Public title
Albumin and Furosemide in Nephrotic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ََAge between 2 to 15 years
Diagnosis of Nephrotic Syndrome
Exclusion criteria:
Allergy to Albumin
Allergy to Furosemide
Urine output less than 0.5 ml/kg/hr
Age
From 2 years old to 15 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization has been performed using the block randomization table. In this method, the total study population is divided into small blocks, and randomization is performed inside the block. This method results in more homogeneity between the intervention and control groups. A list of four patient blocks is generated by sealedenvelope.com site is provided to the designated allocation person, in each recruitment the researcher is informed of allocation by telephone.
Blinding (investigator's opinion)
Double blinded
Blinding description
The medication and placebo will be in look-alike coded packages, and the codes based on the block randomization table will be provided to the researcher by a designated person via phone. At the end of the study, after organizing the data by the same person, the statistical expert will perform the analysis. Then, the code packet will be opened, and the final results will be reported.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
institutional ethics committee for Pharmacy, Nursing and Midwifery Schools
Street address
2nd floor, School of Nursing and Midwifery, Valiasr and Niayesh junction
City
Tehran
Province
Tehran
Postal code
1546815514
Approval date
2021-05-29, 1400/03/08
Ethics committee reference number
IR.SBMU.RICH.REC.1400.018
Health conditions studied
1
Description of health condition studied
Nephrotic syndrome
ICD-10 code
N04
ICD-10 code description
Nephrotic syndrome
Primary outcomes
1
Description
Patient weight
Timepoint
24 hours after intervention
Method of measurement
Weighing the patient
2
Description
urine sodium level
Timepoint
24 hours after intervention
Method of measurement
urine analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Receives a mixture of albumin and furosemide simultaneously. In this group, 10 milligrams of Furosemide is added to a 50 milliliters vial of Albumin 20 percent and for each kilogram of patient weight 5 milliliters would be infused over 1 hour.
Category
Treatment - Drugs
2
Description
Intervention group: Receive Furosemide Upon completion of albumin. In this group, 5 milliliters of Albumin 20 percent for each kilogram of patient weight is infused over one hour, and after completion of infusion 1 milligram of Furosemide injection would be injected into the patient.