Heart Valve DiseasePhase 4NCT01384643
Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery
A Phase 4 study testing Propofol in people with Heart Valve Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Heart Valve Disease
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2011to May 2012
- Phase
- Phase 4
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing valvular heart surgery.
- Age: 20~75.
Who cannot join
- Emergency operation.
- Patients with vitamin E or vitamin C within 5 days before surgery.
- Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
- Patients with serum creatinine ≥ 2.0 mg/dL
- Patients under hemodialysis.
- Patients with acute myocardial infarction within 1 week before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial
Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.
- Conditions
- Heart Valve Disease
- Being tested
- Propofol
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
| Study group | Role | What they receive |
|---|---|---|
| Propofol group | Experimental | Not described Receives: Drug: Propofol |
| Control group | Placebo comparator | Not described Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum creatinine
Comparison of serum creatinine elevation after surgery between Propofol and Control group.
Measured: incidence of AKI during 48 hours after the surgery incidence of AKI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseaseStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384643
- Sponsor's protocol ID
- 1-2011-0007
- Status last verified
- Apr 2013
- First submitted
- 27 Jun 2011
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Propofol on Renal Injury in Patients Undergoing Valvular Heart Surgery: A Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01384643
- Acronym / sponsor ID
- 1-2011-0007
- Conditions
- Heart Valve Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 29 Jun 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.
Ischemia/reperfusion (I/R)-induced acute kidney injury is a serious complication affecting patient outcome following cardiovascular surgeries. Propofol, an intravenously administered anesthetic with antioxidant properties, protects organs from I/R injury. This study aimed to investigate the ability of propofol to protect kidneys against I/R injury in the patients undergoing valvular heart surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol group | Experimental | Drug: Propofol |
| Control group | Placebo comparator | Drug: Propofol |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing valvular heart surgery.
- Age: 20~75.
Key exclusion criteria (6 listed)
- Emergency operation.
- Patients with vitamin E or vitamin C within 5 days before surgery.
- Patients with preoperative C-reactive protein (CRP) > 16 mg/L.
- Patients with serum creatinine ≥ 2.0 mg/dL
- Patients under hemodialysis.
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 |
|---|---|---|
| PropofolInduction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60). | Drug | Control group, Propofol group |
Primary outcome
Serum creatinine
Time frame: incidence of AKI during 48 hours after the surgery incidence of AKI
Comparison of serum creatinine elevation after surgery between Propofol and Control group.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Propofol in people with Heart Valve Disease, 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 6 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 12 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum creatinine (time frame: incidence of AKI during 48 hours after the surgery incidence of AKI). 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 12 Apr 2013.