Dissection of Thoracic AortaPhase 4NCT01369732
Prevention of Acute Kidney Injury by Erythropoietin in Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
A Phase 4 study testing recombinant human erythropoietin and saline in people with Dissection of Thoracic Aorta, run by Yonsei University at 1 site in South Korea.
Trial summary
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Dissection of Thoracic Aorta
- What is being tested?
- recombinant human erythropoietin and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to Jan 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults above age of 20
- Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest
Who cannot join
- pregnancy or lactation
- cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis
- past history of thoracic aortic surgery
- malignancy 5. preoperative acute kidney injury
- chronic renal replacement therapy
- allergy or hypersensitivity to erythropoetin
Show all 10Show fewer
- history of erythropoetin treatment
- death during or one day after surgery
- no consent
- reoperation within seven days of the first surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.
However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.
- Conditions
- Dissection of Thoracic Aorta
- Being tested
- recombinant human erythropoietin, saline
- Medical subject headings
- Dissection, Thoracic Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human erythropoietinDrug
Also called epocaine
We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
salineDrug
Also called normal saline
We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
| Study group | Role | What they receive |
|---|---|---|
| Saline group | Placebo comparator | We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. Receives: Drug: saline |
| erythropoietin group | Experimental | We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. Receives: Drug: recombinant human erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.
Measured: upto 7 days after surgery
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Measured: upto 7 days after surgery
Secondary outcomes (4)
Mortality
Participants will be followed for the mortality, an expected average of 1 month after surgery.
Measured: upto 1 month after surgery
the Duration of Mechanical Ventilation
Participants will be followed for the duration of mechanical ventilation, an expected average of 2 weeks after surgery.
Measured: upto 2 weeks after surgery
the Duration of ICU Stay
Participants will be followed for the duration of ICU stay, an expected average of 2 weeks after surgery.
Measured: upto 2 weeks after surgery
the Duration of Hospital Stay
Participants will be followed for the duration of hospital stay, an expected average of 1 month after surgery.
Measured: upto 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dissection of Thoracic AortaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yon Hee Shim, Study director, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369732
- Sponsor's protocol ID
- 3-2011-0086
- Status last verified
- Jul 2013
- First submitted
- 3 Jun 2011
- Last updated
- 26 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Acute Kidney Injury by Erythropoietin in Patients Undergoing Thoracic Aorta Surgery With Hypothermic Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01369732
- Acronym / sponsor ID
- 3-2011-0086
- Conditions
- Dissection of Thoracic Aorta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 26 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During thoracic aortic surgery, hypothermic cardiac arrest causes aortic ischemia and reperfusion (IR) periods, respectively. Aortic ischemia results in an ischemic insult to the lower extremities and successive reperfusion results in injury to remote organs, including kidneys. So, there has been considerable interest in the development of therapeutic strategies aimed at attenuating IR injury. One such group of agents that are attracting interest due to their potential protective effects on vascular endothelium is the erythropoietin.
However, the effect of erythropoietin on renal injury induced by aortic IR in humane has not been fully clarified. Therefore, the purpose of this study is to determine whether the prophylactic administration of erythropoietin reduce the incidence of acute kidney injury (AKI) in patients undergoing thoracic aorta surgery with hypothermic cardiac arrest. The investigators administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. The differences between the control and study groups are observed by clinical indicators such as serum creatinine, TNF-α, NGAL.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline group | Placebo comparator | Drug: salineWe administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia. |
| erythropoietin group | Experimental | Drug: recombinant human erythropoietinWe administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults above age of 20
- Undergoing Thoracic Aorta Surgery with Hypothermic Cardiac Arrest
Key exclusion criteria (10 listed)
- pregnancy or lactation
- cerebrovascular thrombosis 3. past history of pulmonary embolism or thrombosis
- past history of thoracic aortic surgery
- malignancy 5. preoperative acute kidney injury
- chronic renal replacement therapy
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 |
|---|---|---|
| recombinant human erythropoietinAlso: epocaineWe administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia. | Drug | erythropoietin group |
| salineAlso: normal salineWe administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia. | Drug | Saline group |
Primary outcome
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Time frame: upto 7 days after surgery
Serum creatinine, GFR, urine output will be measured at 6:00 AM everyday up to 7 days after surgery.
Incidence of Acute Kidney Injury Based on RIFLE Criteria
Time frame: upto 7 days after surgery
4 secondary outcomes
Mortality
Time frame: upto 1 month after surgery
the Duration of Mechanical Ventilation
Time frame: upto 2 weeks after surgery
the Duration of ICU Stay
Time frame: upto 2 weeks after surgery
the Duration of Hospital Stay
Time frame: upto 1 month after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Yon Hee Shim study director
Yonsei University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant human erythropoietin and saline in people with Dissection of Thoracic Aorta, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 26 Sep 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Acute Kidney Injury Based on RIFLE Criteria (time frame: upto 7 days after surgery). The study lists 2 primary outcomes in all. 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 26 Sep 2013.