Back to resultsThe Effect of Prophylactic Hemodialysis on the Morbidity and Mortality of the Patients With Chronic Kidney Disease Stages 3-4 Undergoing Coronary Artery Graft Bypass
Primary Purpose
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Coronary Artery Disease
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
hemodialysis
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Kidney Disease stage3
Eligibility Criteria
Inclusion Criteria:
- 80<age>18
- ckd patients with stage 3,4
- CABG for the first time
Exclusion Criteria:
- age<18
- previous CABG (coronary artery bypass grafting)
- AKI(acute kidney injury)
- dialysis patients
Sites / Locations
- Tehran Herat CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
dialysis
control group
Arm Description
the patients who undergo 3 sessions prophylactic hemodialysis
the patients who do not undergo hemodialysis
Outcomes
Primary Outcome Measures
morbidity
morbidity is defined as length of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications,
Secondary Outcome Measures
mortality
Full Information
NCT ID
NCT01410617
First Posted
August 3, 2011
Last Updated
March 25, 2013
Sponsor
Imam Khomeini Hospital
Collaborators
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01410617
Brief Title
The Effect of Prophylactic Hemodialysis on the Morbidity and Mortality of the Patients With Chronic Kidney Disease Stages 3-4 Undergoing Coronary Artery Graft Bypass
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Imam Khomeini Hospital
Collaborators
Tehran University of Medical Sciences
4. Oversight
5. Study Description
Brief Summary
Coronary artery disease is a major cause of death in patients with renal dysfunction Among patients who undergo coronary artery bypass grafting ,renal dysfunction is known To be a major predictor of in-hospital and remote mortality As little is known about the impact of non-dialysis-dependent renal dysfunction on short and mid term Outcomes following coronary surgery we have decided to investigate the effect of prophylactic Hemodialysis on the mortality and morbidity of the patients with ckd (stage 3,4 ) and compare these Effect with the control group
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Coronary Artery Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
dialysis
Arm Type
Active Comparator
Arm Description
the patients who undergo 3 sessions prophylactic hemodialysis
Arm Title
control group
Arm Type
No Intervention
Arm Description
the patients who do not undergo hemodialysis
Intervention Type
Procedure
Intervention Name(s)
hemodialysis
Intervention Description
3 sessions hemodialysis before CABG
Primary Outcome Measure Information:
Title
morbidity
Description
morbidity is defined as length of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications,
Time Frame
the morbidity during the time of hospitalization until discharge (baseline) and six month later
Secondary Outcome Measure Information:
Title
mortality
Time Frame
from the time of CABG (baseline) until six months later
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
80<age>18
ckd patients with stage 3,4
CABG for the first time
Exclusion Criteria:
age<18
previous CABG (coronary artery bypass grafting)
AKI(acute kidney injury)
dialysis patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamamd R khatami, MD
Phone
00982161192659
Email
khatamis@sina.tums.ac.ir
First Name & Middle Initial & Last Name or Official Title & Degree
Roghieh Borji, MD
Phone
009891254590988
Email
soheila1111@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roghieh Borji, MD
Organizational Affiliation
Imam Khomeini Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad R Khatami, MD
Organizational Affiliation
Nephrology research Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seyyed Hossein Ahmadi, MD
Organizational Affiliation
Tehran Herat Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khosro Barkhordari, MD
Organizational Affiliation
Tehran Heart Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohammad R Abbasi, MD
Organizational Affiliation
Nephrology Researc Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran Herat Center
City
Tehran
ZIP/Postal Code
1411713131
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M R Khatami, MD
Email
khatamis@sina.tums.ac.ir
First Name & Middle Initial & Last Name & Degree
R Borji, MD
Email
soheila1111@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammad R Khatami, MD
12. IPD Sharing Statement
Learn more about this trial
The Effect of Prophylactic Hemodialysis on the Morbidity and Mortality of the Patients With Chronic Kidney Disease Stages 3-4 Undergoing Coronary Artery Graft Bypass
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