Chronic Kidney Disease stage3Phase 2/3NCT01410617
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
A Phase 2/3 study testing hemodialysis in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Imam Khomeini Hospital at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Disease stage3, Chronic Kidney Disease stage4, Coronary Artery Disease
- What is being tested?
- hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIran
- Study dates
- Aug 2011to Dec 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 80<age>18
- ckd patients with stage 3,4
- CABG for the first time
Who cannot join
- age<18
- previous CABG (coronary artery bypass grafting)
- AKI(acute kidney injury)
- dialysis patients
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Tehran Herat Center
Tehran, Tehran Province, 1411713131
M R Khatami, MD, khatamis@sina.tums.ac.ir
R Borji, MD, soheila1111@yahoo.com
About this study
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
- Being tested
- hemodialysis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodialysisProcedure or surgery
3 sessions hemodialysis before CABG
| Study group | Role | What they receive |
|---|---|---|
| dialysis | Active comparator | the patients who undergo 3 sessions prophylactic hemodialysis Receives: Procedure: hemodialysis |
| control group | No intervention | the patients who do not undergo hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
morbidity is defined as length of hospitalization,infection rate,duration of mechanical ventilation,bleeding complications,
Measured: the morbidity during the time of hospitalization until discharge (baseline) and six month later
Secondary outcomes (1)
mortality
Measured: from the time of CABG (baseline) until six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease stage3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Khomeini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Responsible party
- Principal investigator, Mohammad Reza Khatami, Imam Khomeini Hospital
- Investigators
- Roghieh Borji, MD, Principal investigator, Imam Khomeini HospitalMohammad R Khatami, MD, Study director, Nephrology research CenterSeyyed Hossein Ahmadi, MD, Study chair, Tehran Herat CenterKhosro Barkhordari, MD, Principal investigator, Tehran Heart CenterMohammad R Abbasi, MD, Principal investigator, Nephrology Researc Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410617
- Sponsor's protocol ID
- THC-473
- Status last verified
- Mar 2013
- First submitted
- 3 Aug 2011
- Last updated
- 27 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01410617
- Acronym / sponsor ID
- THC-473
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imam Khomeini HospitalUniversity, hospital or other
- Collaborators
- Tehran University of Medical Sciences
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 5 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dialysis | Active comparator | Procedure: hemodialysisthe patients who undergo 3 sessions prophylactic hemodialysis |
| control group | No intervention | –the patients who do not undergo hemodialysis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 80<age>18
- ckd patients with stage 3,4
- CABG for the first time
Key exclusion criteria (4 listed)
- age<18
- previous CABG (coronary artery bypass grafting)
- AKI(acute kidney injury)
- dialysis patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodialysis3 sessions hemodialysis before CABG | Procedure or surgery | dialysis |
Primary outcome
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,
1 secondary outcome
mortality
Time frame: from the time of CABG (baseline) until six months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roghieh Borji, MD principal investigator
Imam Khomeini Hospital
Mohammad R Khatami, MD study director
Nephrology research Center
Seyyed Hossein Ahmadi, MD study chair
Tehran Herat Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing hemodialysis in people with Chronic Kidney Disease stage3 and Chronic Kidney Disease stage4, run by Imam Khomeini Hospital at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamamd R khatami, MD (00982161192659, khatamis@sina.tums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: the morbidity during the time of hospitalization until discharge (baseline) and six month later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2013.