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:
Imam Khomeini Hospital
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
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| First Received Date ICMJE | August 3, 2011 | ||||||||||||||||||||
| Last Updated Date | March 25, 2013 | ||||||||||||||||||||
| Start Date ICMJE | August 2011 | ||||||||||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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, |
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| Original Primary Outcome Measures ICMJE |
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 lenghth of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications, |
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| Change History | Complete list of historical versions of study NCT01410617 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
mortality [ Time Frame: from the time of CABG (baseline) until six months later ] [ Designated as safety issue: Yes ] | ||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||
| Brief Title ICMJE | 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 | ||||||||||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||||||||||
| 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 |
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| Detailed Description | Not Provided | ||||||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: hemodialysis
3 sessions hemodialysis before CABG |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||||||
| Estimated Enrollment ICMJE | 120 | ||||||||||||||||||||
| Estimated Completion Date | December 2013 | ||||||||||||||||||||
| Estimated Primary Completion Date | September 2013 (final data collection date for primary outcome measure) | ||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||||||
| Ages | 18 Years to 80 Years | ||||||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Iran, Islamic Republic of | ||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||
| NCT Number ICMJE | NCT01410617 | ||||||||||||||||||||
| Other Study ID Numbers ICMJE | THC-473 | ||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||||||||||
| Responsible Party | Mohammad Reza Khatami, Imam Khomeini Hospital | ||||||||||||||||||||
| Study Sponsor ICMJE | Imam Khomeini Hospital | ||||||||||||||||||||
| Collaborators ICMJE | Tehran University of Medical Sciences | ||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Imam Khomeini Hospital | ||||||||||||||||||||
| Verification Date | March 2013 | ||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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