The aim of this study is to determine the efficacy of furosemide-albumin compared to furosemide in oligouric hypoalbuminemic patients. After approval of the ethics committee of Tabriz University of Medical Sciences, 10 patients admitted to the intensive care unit with oligouria and serum albumin less than 3g/dl and requiring the use of furosemide to increase urine output will be included in the study. They will be randomized into two groups as albumine/furosemide group or furosemide group. In the furosemide group, patients will receive 60 mg lasix in 100 ml normal saline in 30 minutes; and in the albumine/furosemide group, patients will receive 60 mg lasix in 100 ml albumine in 30 minutes. 24-hour urine sample will be collected every 2 hours until 12 hours and then one sample for the next 12 hour; and urinary concentration of sodium and furosemide will be reported with HPLC method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412132582N12
Registration date:2015-02-23, 1393/12/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-23, 1393/12/04
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research deputy of Tabriz University of Medical Sciences
Expected recruitment start date
2014-12-21, 1393/09/30
Expected recruitment end date
2015-02-18, 1393/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of furosemide-albumin compared to furosemide in oligouric hypoalbuminemic patients
Public title
Effect of albumine- furosemide in oligouric patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients admitted to the intensive care unit; oligouria; serum albumin<3g/dl; generalized edema; requiring the use of furosemide to increase urine output
Exclusion criteria: serum albumin>3g/dl; nonoligouric acute renal failure; balance of fluid loaded to the patient and no need for greater diuresis by the physician; receiving diuretics in the past 48 hours; hemodynamically unstable patients with vasopressor dependence; pregnancy; ESRD patients with anuria, cirrhosis, nephrotic syndrome, cardiogenic shock and CRF
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2014-09-08, 1393/06/17
Ethics committee reference number
5/4/5555
Health conditions studied
1
Description of health condition studied
AKI
ICD-10 code
N17.9
ICD-10 code description
Acute renal failure, unspecified
Primary outcomes
1
Description
urinary furosemide
Timepoint
24-hour urine sample will be collected every 2 hours until 12 hours and then one sample for the next 12 hours
Method of measurement
HPLC
Secondary outcomes
1
Description
Urinary Na
Timepoint
Urine sampling will be at 8-10,10-12,12-14, 14-16,16-18 and 18-20 o,clock and then 20 till 8 in the next day,s morning
Method of measurement
HPLC
Intervention groups
1
Description
In the furosemide/Albumine(intervention) group patients received 60 mg lasix in 100 ml albumine in 30 minutes.
Category
Treatment - Drugs
2
Description
In furosemide(Control) group patients received 60 mg lasix in 100 ml normal saline in 30 minutes.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Shohada hospital, El-goli street
City
Tabriz
2
Recruitment center
Name of recruitment center
General intensive care unit of Imam Reza hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
Imam Reza hospital, Golgasht street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Farhudi
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Shahabi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
farnazshahabi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
Associate professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
amahmoodpoor@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research deputy of Tabriz University of Medical Ssciences
Full name of responsible person
Farnaz Shahabi
Position
Anesthesiology resident
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
farnazshahabi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)