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

March 25, 2013 updated by: Mohammad Reza Khatami, Imam Khomeini Hospital
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
the morbidity during the time of hospitalization until discharge (baseline) and six month later

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: from the time of CABG (baseline) until six months later
from the time of CABG (baseline) until six months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Khomeini Hospital

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 3, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

March 27, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • THC-473

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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