Cardiopulmonary BypassPhase 1NCT00385450
Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor
A Phase 1 study of Cardiopulmonary Bypass, run by Mayo Clinic at 1 site in United States.
Trial summary
In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Bypass
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Oct 2008
- Phase
- Phase 1
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.
Who cannot join
- A dozen different medical conditions and two dozen medical contraindications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period
In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.
Read the detailed description
See Brief Summary.
- Conditions
- Cardiopulmonary Bypass
- Being tested
- Nelfinavir/placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir/placeboDrug
1250mg/twice each day/four days.
| Study group | Role | What they receive |
|---|---|---|
| Nelfinavir/placebo | Experimental | Not described Receives: Drug: Nelfinavir/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter
Measured: Six days.
Secondary outcomes (2)
Changes in quantitative measure of inflammatory markers
Measured: Six days.
Changes in clinical outcomes.
Measured: Six days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Study closed at Mayo prior to completion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary BypassStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Andrew D. Badley, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00385450
- Sponsor's protocol ID
- 05-004052 00
- Status last verified
- Apr 2015
- First submitted
- 5 Oct 2006
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor in the Perioperative Period
- ClinicalTrials.gov ID
- NCT00385450
- Acronym / sponsor ID
- 05-004052 00
- Conditions
- Cardiopulmonary Bypass
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed at Mayo prior to completion
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 9 Oct 2006 (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.
In previous studies, 90% of patients who underwent elective cardiopulmonary bypass procedure manifested CD4 counts of less than 500 cells/microliter in the immediate (day 1) post-operative period. This study will investigate whether or not Nelfinavir increases those CD4 counts in the post-operative period.
Detailed description
See Brief Summary.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nelfinavir/placebo | Experimental | Drug: Nelfinavir/placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient undergoing elective (non-emergency) cardiopulmonary bypass for coronary artery bypass grafting, cardiac valve replacement, or both.
Key exclusion criteria (1 listed)
- A dozen different medical conditions and two dozen medical contraindications.
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 |
|---|---|---|
| Nelfinavir/placebo1250mg/twice each day/four days. | Drug | Nelfinavir/placebo |
Primary outcome
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter
Time frame: Six days.
2 secondary outcomes
Changes in quantitative measure of inflammatory markers
Time frame: Six days.
Changes in clinical outcomes.
Time frame: Six days.
Results and safety
The study was stopped early (reason given: Study closed at Mayo prior to completion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
Andrew D. Badley, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Cardiopulmonary Bypass, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 28 Apr 2015. 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 United States. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Study closed at Mayo prior to completion). Results are not available in the source record.
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?
Proportion of Nelfinavir patients v. proportion of placebo patients who have CD4 counts of less than 500 cells/microliter (time frame: Six days.). 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 28 Apr 2015.