Protocol summary

Summary
Main purpose of the study : treatment ( Role of early hemodialysis on acute kidney injury in critically ill patients ) . Study design: interventional, non-randomized, double blind and parallel without placebo. Target sample size: 60 patients from both sexes between ages 18 and 60. If there is one of the following scales such as , at least 50% creatinine rise from the admission time , BUN>70, oliguria <0.5 ml/kg/h for 12 hours with no response to volume and Furosemide , anuria <0.3 ml/kg/h for 6 hours with no response to volume and Furosemide, will be specified as Early Hemodialysis Group (D) and if there is criteria such as volume overload ( pulmonary edema) , BUN>100 or occurance of azotemia complications (ex:loss of Consciousness ) and cr>4 will be specified as Group C. In case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ), infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study. Exclusion criteria: history of renal insufficiency , reception of high dose inotropics, septic shock , severe electrolyte abnormalities leading to hemodialysis. Intervention: hemodialysis central vein catheter will be inserted for the patients and dialysis will start daily ( 2 hours for the first day then 4 hours). Dialysis will be done at least for 3 days and in case of appropriate urination , correction of urea or creatinine, dialysis implementation will be every other day for about 3 hours. When the blood urea and creatinine are stabled, the dialysis is suspended and restarting is according to mentioned indications. Primary outcome measure: plasma creatinine,blood urea and urine volume. Secondary outcome measure : length of stay and mortality rate in intensive care unit.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201507069045N3
Registration date: 2016-04-03, 1395/01/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Mohammad Taghi Beigmohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2511
Email address
beigmohammadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Role of early hemodialysis on acute kidney injury in critically ill patients at Tehran Imam Khomeini Hospital
Public title
Role of early hemodialysis on acute kidney injury in critically ill patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: if there is one of the following scales such as ; at least 50% creatinine rise from the admission time ; BUN>70 ; oliguria <0.5 ml/kg/h for 12 hours with no response to volume and Furosemide ; anuria <0.3 ml/kg/h for 6 hours with no response to volume and Furosemide; will be specified as Early Hemodialysis Group (D) and if there is criteria such as volume overload ( pulmonary edema) ; BUN>100 or occurance of azotemia complications ( ex:loss of Consciousness ) and cr>4 will be specified as Group C. In case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ) , infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study; Exclusion criteria: history of renal insufficiency ; reception of high dose inotropics; septic shock ; severe electrolyte abnormalities leading to hemodialysis.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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 Tehran University of Medical Sciences
Street address
Keshavarz Boulevard,Amir Abad, Tehran
City
Tehran
Postal code
Approval date
2015-07-05, 1394/04/14
Ethics committee reference number
IR.TUMS.REC.1394.342

Health conditions studied

1

Description of health condition studied
Acute renal injury
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood urea
Timepoint
Before intervention, daily after intervention
Method of measurement
Blood sample

2

Description
Plasma creatinine
Timepoint
Before intervention, daily after intervention
Method of measurement
Blood sample

3

Description
Urine volume
Timepoint
Before intervention, daily after intervention
Method of measurement
Fully catheter and urine bag

Secondary outcomes

1

Description
Length of stay in intensive care unit
Timepoint
Daily
Method of measurement
Number of admission days in intensive care unit

2

Description
Mortality rate in intensive care unit
Timepoint
Daily
Method of measurement
Rate of 28-day mortality

Intervention groups

1

Description
For early Hemodialysis Group (D) , central vein catheter will be inserted for the patients and dialysis will start daily ( 2 hours for the first day then 4 hours). Dialysis will be done at least for 3 days and in case of appropriate urination , correction of urea or creatinine, dialysis implementation will be every other day for about 3 hours. When the blood urea and creatinine are stabled, the dialysis is suspended and restarting is according to mentioned indications.Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran.
Category
Treatment - Other

2

Description
Control group: in case of oliguria (U/O<0.5 ml/kg/h) or aniria (U/O<0.3 ml/kg/h or cessation of urine ) , infusion of 500 ml crystalloid with 60 mg Furosemide in 1 hour will be administered and while there is no response , the patient entered the study and hemodialysis will started after inserting central vein catheter . Solution for the hemodialysis: acidic hemodialysis concentrated 2.4920 ml.The solution must be diluted 35 times immediately before use.For this purpose ,add 1 liter of concentrated solution to 34 liter pure water.In case of turbid liquid or particles ,it is not usable.After use,the remaining solution must be discarded.Sodium bicarbonate will be added immediately before use.This solution contains: sodium chloride,potassium chloride, magnesium chloride,calcium chloride,glacial acetic acid,dextrose.Electrolytes are: sodium, potassium, magnesium, calcium, chloride, acetate.Maintanance condition: the solution must be away from light and kept under 30 c and protected from freezing.It is a product of Faran pharmaceutical chemical company,Tuyserkan,Iran.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Intensive care units of Imam Khomeini Hospital
Full name of responsible person
Mohammad Taghi Beigmohammadi.MD
Street address
Imam Khomeini Hospital, Keshavarz Boulevard, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research , Tehran University of Medical Sciences
Full name of responsible person
Seyed Ahmad Rezaii
Street address
Keshavarz Boulevard , Amir Abad , Tehran
City
Tehran
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 , Tehran 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
Imam Khomeini Hospital Complex
Full name of responsible person
Mohammad Taghi Beigmohammadi.MD
Position
Head of Intensive Care Units
Other areas of specialty/work
Street address
Cancer institute , Imam Khomeini hospital, Keshavarz boulevard, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2511
Fax
Email
mbage46@gmail.com; beigmohammadi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Imam Khomeini Hospital Complex
Full name of responsible person
Mohammad Taghi Beigmohammadi.MD
Position
Intensivist
Other areas of specialty/work
Street address
Cancer institute, Imam Khomeini Hospital , Keshavarz boulevard , Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2511
Fax
Email
mbage46@gmail.com; beigmohammadi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mojdeh Nouhravesh.MD
Position
Other areas of specialty/work
Street address
Imam Khomeini Hospital , Keshavarz boulevard,Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
mojdeh.nouhravesh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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