considering effect of serum with bicarbonate and serum without bicarbonate with soduim in treatment of hemolysis caused by glucose 6-phosphate dehydrogenase deficiency
Objective of this proposal is evaluation of possible side effects of sodium bicarbonate and its effect in treatment of Hemolytic anemia due to G6PD deficiency. Inclusion criteria are just diagnosis favism. Beans consumption and highlighted in urine are the first items for diagnosis of favism and it is confirmed by urinalysis that is hemoglobinuria positive. Exclusion criteria are dissatisfaction. All of people admitted to emergency department of Taleghani hospital in determined time and with favism will be studied. There are not any special age ranges.
After evaluation of clinical and paraclinical factors, patients will be divided in 3 groups: 1) in hemoglobin <7 g/dl, patient will receive packed cell and treat by serum with bicarbonate or serum without bicarbonate and with sodium randomly; 2) in hemoglobin 7-9 g/dl, with hemoglobinuria, will be done like previous protocol and without hemoglobinuria, the patient is hospitalized for 24 hours. After backing to 1 or 2 situation, will be done according to determined protocol; and 3) in hemoglobin >9 g/dl and with hemoglobinuria, will be done according to this method and without hemoglobinuria, patient will be excluded. The clinical and paraclinical factors will be evaluated again before discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031012765N1
Registration date:2013-04-21, 1392/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-21, 1392/02/01
Registrant information
Name
Azam Rashidbaghan
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 1232 8539
Email address
hocr@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology,Golestan University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
considering effect of serum with bicarbonate and serum without bicarbonate with soduim in treatment of hemolysis caused by glucose 6-phosphate dehydrogenase deficiency
Public title
Comparison efficacy of tow serum therapy methods (serum with bicarbonate and without bicarbonate with soduim) in some factors (cratinin, pH of urine, term negative UA in terms of hemoglobin and granular casts) patients with hemolysis caused by glucose 6-phosphate dehydrogenase enzyme deficiency in Taleghani hospital, Gorgan
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria is just diagnosis favism. Beans consumption and Highlighted in urine are the first items for diagnosis of favism and it is confirmed by urinalysis that is Hemoglobinuria positive. Exclusion criteria is dissatisfaction.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
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 Golestan University of Medical Sciences
Street address
Falsafi Higher Education Bilding, Bigining of Shatkola Roade
City
Gorgan
Postal code
Approval date
2013-02-13, 1391/11/25
Ethics committee reference number
29451391112921
Health conditions studied
1
Description of health condition studied
hemolysis due to glucose 6-phasphate deficiency
ICD-10 code
D55.0
ICD-10 code description
Anaemia due to glucose-6-phosphate dehydrogenase [G6PD] deficiency
Primary outcomes
1
Description
hemoglpbine
Timepoint
befor intevention and after intervention, befor discharge
Method of measurement
g/dl- according to tests
2
Description
cereatinine
Timepoint
befor intevention and after intervention, befor discharge
Method of measurement
mg/dl- according to tests
3
Description
pH of urine
Timepoint
befor intevention and after intervention, befor discharge
Method of measurement
by pH meter
4
Description
UA-cast
Timepoint
befor intevention and after intervention, befor discharge
Method of measurement
BY Urinanalysis
Secondary outcomes
1
Description
Time of admission until discharge
Timepoint
at discharge
Method of measurement
Measuring the time from the moment of admission to hospital discharge
2
Description
number of blood transfusion
Timepoint
during treatment
Method of measurement
The frequency of blood transfusion
3
Description
Blood volume injected for each time
Timepoint
during intervention
Method of measurement
ml- Based on the amount of blood recieved at every turn
4
Description
Time to clear urine
Timepoint
at the end of intervention
Method of measurement
being negative urine from hemoglobinuria
5
Description
side effects of ficarbonate
Timepoint
after intervention
Method of measurement
basis on observed side effects
Intervention groups
1
Description
treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of bicarbonate
Category
Treatment - Drugs
2
Description
treatment by serum with bicarbonate, 1.5 times of Maintaining serum volume of dextrose water 5% and for 100 mililiter, 3 meq/lit of NaCl.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology and Oncology Research Center
Full name of responsible person
Narges beigom Mirbehbahani
Street address
Taleghani Hospital, Janbazan Boulevard
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology- Golestan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jfar Golalipour
Street address
Falsafi Higher Education Bilding, Bigining of Shastkola roade
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology- Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology & Oncology Research Center, Golestan University of Medical Sciences