The Effect of Prophylactic Dialysis on the Mortality and Morbidity of Patients with Moderate Chronic Kidney Diseaeses undergoing Coronary Artery Bypass.
In our study we evaluate the effect of prophylactic hemodialysis in patients with chronic kidney disease stage 3-4 who undergo coronary artery bypass graft. In our randomized non-blinded trial, 120 patients with establishe chronic kidney disease satege 3-4 will be enrolled into the study after signing the written consent. They will be randomly allocated as case (dialysis group) and control groups( non dialysis group). The case group will be dialysed 3 sessions before surgery . The patients will be followed for mortality and morbidity during hospitalization and for one month after discharge from the hospital.the date will be analysed and compared within two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011065113N1
Registration date:2012-02-02, 1390/11/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-02, 1390/11/13
Registrant information
Name
Seyyed Mohammad Reza Khatami
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2659
Email address
khatamis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
by a grant of deputy research of Tehran University of Medical Sciences
Expected recruitment start date
2011-07-01, 1390/04/10
Expected recruitment end date
2012-10-01, 1391/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Prophylactic Dialysis on the Mortality and Morbidity of Patients with Moderate Chronic Kidney Diseaeses undergoing Coronary Artery Bypass.
Public title
Prophylactic Dialysis in CABG Patients with Moderate Renal Failure
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: age more tha 18 years; patients with GFR between 15 and 59 ml/ min/1.73 m2 body surface; patients undergoing CABG
exclusion criteria: CABG for second time or more; CABG in Association with other heart surgery; patients with acute kidney injury
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
the ethic committee of deputy research of Tehran University of Medical Sciences
Street address
Central Campus of Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
٥٤٧
Health conditions studied
1
Description of health condition studied
Chrinic Kidney Disease stage 3-4
ICD-10 code
N18.3 and
ICD-10 code description
فیلتراسیوت گلومرولی کمتر از 60 میلی ایتر در دقیقه و بالاتر از 15 میلی لیتر در دقیقه
Primary outcomes
1
Description
Hospital stay
Timepoint
Daily
Method of measurement
The time of discharge
2
Description
Acute kidney injury
Timepoint
Daily
Method of measurement
Serum Creatinie
3
Description
Cerebro vascular accident
Timepoint
Daily
Method of measurement
MRI
4
Description
Transient ischemic attack
Timepoint
Daily
Method of measurement
neurologic exam
5
Description
Atrial arrhythmia after surgery
Timepoint
Daily
Method of measurement
Ekg monitoring
6
Description
Sternum infection
Timepoint
Daily
Method of measurement
Clinical evaluation and culture
7
Description
Re operation due to bleeding
Timepoint
Daily
Method of measurement
Observation
8
Description
Lung complications
Timepoint
Daily
Method of measurement
Observation and paraclinic evaluation like chest x ray
9
Description
Duration of being on ventilator
Timepoint
Daily
Method of measurement
Patients' medical file
10
Description
Staying time in I C U
Timepoint
Daily
Method of measurement
Medical file
11
Description
mortality and morbidity
Timepoint
Time of death
Method of measurement
Death
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: An central catheter will be inserted 6 days before surgery in case group and 3 sessions hemodialysis will be delivered in everyother day . The first session for 2 hours, the second session for 3 hours and the last session for 4 hours
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Seyyed Mohammad Reza Khatami
Street address
Imam khomeini hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Reza Khatami
Street address
Imam khomeini hospital, keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center, 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
Nephrology Research Center
Full name of responsible person
Seyyed Mohammad Reza Khatami
Position
Associate Professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
khatamis@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Imam Khomeini Hospital
Full name of responsible person
Rogheyeh Borji
Position
Assistant
Other areas of specialty/work
Street address
Keshavarz Blvd. Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
soheila1111@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)