Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments
The aim of this study is to determine the frequency of nephropathy-induced by acute hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency treated with 3 different fluid therapy methods.
Design
A clinical trial with a control group, with parallel-group, randomized, 132 patients, phase 3
Settings and conduct
In this randomized double-blind clinical trial study, infants and children aged 3 months to 18 years with acute hemolysis due to G6PD deficiency admitted to Shahrivar Hospital in Rasht in 1398 requiring at least 24 hours fluid therapy and hospitalization for follow-up will be studying for 24 to 72 hours.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 3 months to 18 years, urinary hemoglobin more or equal to + 2, need to receive intravenous fluids for at least 24 hours, acute hemolysis caused by favism or G6PD deficiency, hospitalization for 24 to 72 hours
Exclusion criteria: Patients will be excluded if any of the following adverse events occur: sodium levels below 130 and above 150, neurological symptoms of hyponatremia, symptoms of fluid retention and general puffiness,Oligo Anuric renal failure
Intervention groups
Intervention group 1: Receiving 1.5 folds of maintenance normal saline serum which will be continued until discharge, Intervention group 2: Receiving 1.5 folds of maintenance half saline which will be continued until discharge + 7 cc bicarbonate/liter, Intervention group 3: Receiving 1.5 folds of maintenance normal saline which will be continued until discharge + 5 mg/ kg/ day Acetazolamide for 48 hours
Main outcome variables
The Frequency of Nephropathy due to Acute Hemolysis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090111001545N5
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Hamidreza Badeli
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 9523
Email address
badeli@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments
Public title
Comparison of the frequency of acute hemolysis induced nephropathy in patients with glucose 6 phosphate dehydrogenase deficiency treated with 3 different therapeutic fluid treatments
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age : 3 months - 18 years old
hemoglobinuria ≥ 2+
intra venous fluid therapy for at least 24 hours
acute hemolysis induced Favism or glucose 6 phosphate dehydrogenase deficiency
hospitalization for 24 to 72 hours
Exclusion criteria:
Presence of Dysatremia
Central Diabetes insipidus or renal Diabetes insipidus
Barrett's Syndrome
Nephrotic Syndrome
Chronic Kidney Disease
Congestive heart failure
Liver cirrhosis
Metabolic diseases
Diabetic ketoacidosis
Congenital adrenal hypoplasia
shock
Glaucoma
Addison's disease
Unwiling to participate
Age
From 3 months old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table
Patients who met the inclusion criteria were selected by a random number table from left to right reading method. The numbers were between 00 and44 in group1 and patients with numbers between 44 and 88 in group 2 and patients with numbers from 88 to132 were divided into group 3.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Siadati
City
Rasht
Province
Guilan
Postal code
4144654679
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.GUMS.REC.1398.026
Health conditions studied
1
Description of health condition studied
Glucose 6 Phosphate Dehydrogenase Deficiency
ICD-10 code
D55.0
ICD-10 code description
Anemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
Primary outcomes
1
Description
The Frequency of Nephropathy due to Acute Hemolysis
Timepoint
Assessing the frequency of Nephropathy before intervention and 6, 12, 24, 48, and 72 hours after intervention
Method of measurement
Laboratory examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Receiving 1.5 folds of maintenance normal saline serum which will be continued until discharge, Intervention group 2: Receiving 1.5 folds of maintenance half saline which will be continued until discharge + 7 cc bicarbonate/liter, Intervention group 3: Receiving 1.5 folds of maintenance normal saline which will be continued until discharge + 5 mg/ kg/ day Acetazolamide for 48 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17-Shahrivar Children Hospital
Full name of responsible person
Hamidreza Badeli
Street address
Siadati St
City
Rasht
Province
Guilan
Postal code
41144654839
Phone
+98 13 3336 9002
Fax
+98 13 3336 9061
Email
badeli45@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor of Reserach- Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Namjou Ave,Shadid Siadati St,Rasht
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9002
Fax
+98 13 3336 9070
Email
badeli45@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Email
badeli45@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Hamidreza Badeli
Position
Nephrologist and Associate Professor of Guilan University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Shahid Siadati Street
City
Rasht
Province
Guilan
Postal code
4144654679
Phone
+98 13 3336 9002
Fax
Email
badeli45@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD