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
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 3, 2011
CompletedFirst Posted
Study publicly available on registry
August 5, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMarch 27, 2013
March 1, 2013
2.1 years
August 3, 2011
March 25, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
morbidity
morbidity is defined as length of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications,
the morbidity during the time of hospitalization until discharge (baseline) and six month later
Secondary Outcomes (1)
mortality
from the time of CABG (baseline) until six months later
Study Arms (2)
dialysis
ACTIVE COMPARATORthe patients who undergo 3 sessions prophylactic hemodialysis
control group
NO INTERVENTIONthe patients who do not undergo hemodialysis
Interventions
Eligibility Criteria
You may qualify if:
- \<age\>18
- ckd patients with stage 3,4
- CABG for the first time
You may not qualify if:
- age\<18
- previous CABG (coronary artery bypass grafting)
- AKI(acute kidney injury)
- dialysis patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imam Khomeini Hospitallead
- Tehran University of Medical Sciencescollaborator
Study Sites (1)
Tehran Herat Center
Tehran, Tehran Province, 1411713131, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roghieh Borji, MD
Imam Khomeini Hospital
- STUDY DIRECTOR
Mohammad R Khatami, MD
Nephrology research Center
- STUDY CHAIR
Seyyed Hossein Ahmadi, MD
Tehran Herat Center
- PRINCIPAL INVESTIGATOR
Khosro Barkhordari, MD
Tehran Heart Center
- PRINCIPAL INVESTIGATOR
Mohammad R Abbasi, MD
Nephrology Researc Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Member of research board of Nephrology ResearchCenter of Tehran University of Medical Sciences
Study Record Dates
First Submitted
August 3, 2011
First Posted
August 5, 2011
Study Start
August 1, 2011
Primary Completion
September 1, 2013
Study Completion
December 1, 2013
Last Updated
March 27, 2013
Record last verified: 2013-03