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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01410617
• Other study ID #: THC-473
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 3, 2011
• Last updated: March 25, 2013
• Start date: August 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Imam Khomeini Hospital
• Contact: Mohamamd R khatami, MD
• Phone: 00982161192659
• Email: khatamis[@]sina.tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran:deputy Research of Tehran University of Medical Sciences
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Kidney Disease stage3
• Chronic Kidney Disease stage4
• Coronary Artery Disease
• Coronary Disease
• Kidney Diseases
• Myocardial Ischemia
• Renal Insufficiency, Chronic

Intervention

Procedure:
• hemodialysis
3 sessions hemodialysis before CABG

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran Herat Center	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Imam Khomeini Hospital	Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	mortality		from the time of CABG (baseline) until six months later	Yes