A clinical trial of comparing the effect of Albumin administration on urine output when using with lasix and mannitol with using lasix and mannitol without Albumin in oliguric patients in ICU
The main objective of this study is investigating the effect of Albumin on urine output, using it with lasix and mannitol in ICU patients with oliguria. This is a clinical trial on 100 patients in ICU who are suffering from acute renal failure and oliguria. Sampling will done using availability sampling method of patients in ICUs of Bahonar hospital of Kerman.
Inclusion criteria: oliguric patients in ICU; patients with Acute Renal Failure. Exclusion criteria: history of kidney disorders (Cr>1.5mg/dl); proteinuria (urine pr>3.5g/d); kidney disorders like glomerulonephritis and ATN; consumption of furosemide within last two weeks; incorrect urine collection; urine line blockage; low level of albumin (below 4.5 mg/dl).
The subjects are divided into two groups of intervention and control using simple randomization by means of draw.
In intervention group in addition of lasix and mannitol, Albumin is administered. In control group just lasix and mannitol are given.
Central venous Pressure, superficial edema and the ratio of PAO2/FIO2 will be measured before commerce of diuresis and during therapeutic period. Urine output is measured every 6 hours. BUN and Cr are measured at the time of admission and then daily. Glomerular filtration rate (GFR) is measured before commerce of diuresis and after starting diuresis.
finally the collected data will be analyzed according to the study's objectives.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016013010741N3
Registration date:2016-04-28, 1395/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-28, 1395/02/09
Registrant information
Name
Minoo Ghahraman
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 5814
Email address
m_ghahraman@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial of comparing the effect of Albumin administration on urine output when using with lasix and mannitol with using lasix and mannitol without Albumin in oliguric patients in ICU
Public title
Investigating the effect of Albumin on urine output, using it with lasix and mannitol in ICU patients with oliguria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: oliguric patients in ICU; patients with Acute Renal Failure.
Exclusion criteria: history of kidney disorders (Cr>1.5mg/dl); proteinuria (urine pr>3.5g/d); kidney disorders like glomerulonephritis and ATN; consumption of furosemide within last two weeks; incorrect urine collection; urine line blockage; low level of albumin (below 4.5 mg/dl).
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Kerman University Medical Sciences
Street address
Kerman University Medical Sciences, Shafa Square
City
Kerman
Postal code
Approval date
2016-04-03, 1395/01/15
Ethics committee reference number
ir.kmu.rec.1394.710
Health conditions studied
1
Description of health condition studied
Acute renal failure
ICD-10 code
N17.9
ICD-10 code description
Acute renal failure, unspecified
Primary outcomes
1
Description
Serum BUN level
Timepoint
At the time of admission and then daily
Method of measurement
Blood test
2
Description
Serum Cr level
Timepoint
At the time of admission and then daily
Method of measurement
Blood test
Secondary outcomes
1
Description
Daily urine output
Timepoint
During hospital stay daily
Method of measurement
Documentation of collected urine in 24 hours
2
Description
Glomerular filtration rate (GFR)
Timepoint
Every day during hospital stay
Method of measurement
By means of creatinine clearance equation
3
Description
CVP
Timepoint
Before commerce of diuresis and during therapeutic period
Method of measurement
Monitoring device
4
Description
Superficial edema
Timepoint
Before commerce of diuresis and during therapeutic period
Method of measurement
Examination
Intervention groups
1
Description
In intervention group in addition to mannitol and lasix (400 mg lasix plus 100 ml mannitol 20% administering 1 mg/kg/h for 2 consecutive days), albumin (one vial of albumin 20% in 1 litre normal saline 2 times a day for 2 consecutive days) is given.
Category
Treatment - Drugs
2
Description
In control group mannitol and lasix (400 mg lasix plus 100 ml mannitol 20% administering 1 mg/kg/h for 2 consecutive days) is given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahonar Hospital
Full name of responsible person
Mehdi Ahmadinejad
Street address
Bahonar Hospital, Bagh-e-melli square
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Minoo Ghahraman
Position
Anesthesiologist
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
m_ghahraman@kmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahamadinejad
Position
Anesthesiologist
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
M_ahmadinejad@kmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Farrokhabadi
Position
MD, Resident of Anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
mfarrokhabadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)