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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01410617
Recruitment Status : Unknown
Verified March 2013 by Mohammad Reza Khatami, Imam Khomeini Hospital.
Recruitment status was:  Recruiting
First Posted : August 5, 2011
Last Update Posted : March 27, 2013
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital

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

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease stage3 Chronic Kidney Disease stage4 Coronary Artery Disease Procedure: hemodialysis Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2011
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: dialysis
the patients who undergo 3 sessions prophylactic hemodialysis
Procedure: hemodialysis
3 sessions hemodialysis before CABG

No Intervention: control group
the patients who do not undergo hemodialysis

Primary Outcome Measures :
  1. morbidity [ Time Frame: the morbidity during the time of hospitalization until discharge (baseline) and six month later ]
    morbidity is defined as length of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications,

Secondary Outcome Measures :
  1. mortality [ Time Frame: from the time of CABG (baseline) until six months later ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01410617

Contact: Mohamamd R khatami, MD 00982161192659
Contact: Roghieh Borji, MD 009891254590988

Iran, Islamic Republic of
Tehran Herat Center Recruiting
Tehran, Iran, Islamic Republic of, 1411713131
Contact: M R Khatami, MD   
Contact: R Borji, MD   
Principal Investigator: Mohammad R Khatami, MD         
Sponsors and Collaborators
Imam Khomeini Hospital
Tehran University of Medical Sciences
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

Responsible Party: Mohammad Reza Khatami, Member of research board of Nephrology ResearchCenter of Tehran University of Medical Sciences, Imam Khomeini Hospital Identifier: NCT01410617     History of Changes
Other Study ID Numbers: THC-473
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: March 27, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Kidney Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Renal Insufficiency, Chronic
Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Renal Insufficiency