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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

This study is currently recruiting participants.
Verified March 2013 by Imam Khomeini Hospital
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Mohammad Reza Khatami, Imam Khomeini Hospital
ClinicalTrials.gov Identifier:
NCT01410617
First received: August 3, 2011
Last updated: March 25, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Chronic Kidney Disease stage3
Chronic Kidney Disease stage4
Coronary Artery Disease
 Procedure: hemodialysis
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imam Khomeini Hospital:

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


Secondary Outcome Measures:
  • mortality [ Time Frame: from the time of CABG (baseline) until six months later ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01410617

Contacts
Contact: Mohamamd R khatami, MD 00982161192659 khatamis@sina.tums.ac.ir
Contact: Roghieh Borji, MD 009891254590988 soheila1111@yahoo.com

Locations
Iran, Islamic Republic of
Tehran Herat Center Recruiting
Tehran, Iran, Islamic Republic of, 1411713131
Contact: M R Khatami, MD         khatamis@sina.tums.ac.ir    
Contact: R Borji, MD         soheila1111@yahoo.com    
Principal Investigator: Mohammad R Khatami, MD            
Sponsors and Collaborators
Imam Khomeini Hospital
Tehran University of Medical Sciences
Investigators
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
  More Information

No publications provided

Responsible Party: Mohammad Reza Khatami, Member of research board of Nephrology ResearchCenter of Tehran University of Medical Sciences, Imam Khomeini Hospital
ClinicalTrials.gov Identifier: NCT01410617     History of Changes
Other Study ID Numbers: THC-473
Study First Received: August 3, 2011
Last Updated: March 25, 2013
Health Authority: Iran:deputy Research of Tehran University of Medical Sciences

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

ClinicalTrials.gov processed this record on May 19, 2013