Peripheral Circulation During On-pump Cardiac SurgeryNCT02329392
Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass
An observational study of Peripheral Circulation During On-pump Cardiac Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Circulation During On-pump Cardiac Surgery
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Dec 2015
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patinets > 20 years old who are scheduled for elective on-pump cardiac surgery
Who may be able to join
- age > 20 yrs, scheduled for elective on-pump cardiac surgery
Who cannot join
- known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate > 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate
Trial locations and contacts
1 site in 1 country.
About this study
This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SPP | Patients undergoing cardiac surgery with perioperative monitoring of Skin Perfusion Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of skin perfusion pressure
Measured: From post induction to 6 hours
Secondary outcomes (1)
Assessment of arterial lactate level
Measured: From post induction to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Circulation During On-pump Cardiac SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 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
- NCT02329392
- Sponsor's protocol ID
- 1-2014-0070
- Status last verified
- Apr 2016
- First submitted
- 29 Dec 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Perfusion Pressure as an Indicator of Tissue Oxygenation in Cardiac Surgery Patients Undergoing Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02329392
- Acronym / sponsor ID
- 1-2014-0070
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 31 Dec 2014 (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.
This study is aim to evaluate usefulness of the perioperative monitoring of skin perfusion pressure as an indicator of perpheral perfusion in patients undergoing on-pump cardiac surgery. Association of the intraoperative and postoperative 6hr skin perfusion pressure with perioperative serum lactate level is going to be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPP | – | –Patients undergoing cardiac surgery with perioperative monitoring of Skin Perfusion Pressure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patinets > 20 years old who are scheduled for elective on-pump cardiac surgery
Key inclusion criteria (1 listed)
- age > 20 yrs, scheduled for elective on-pump cardiac surgery
Key exclusion criteria (1 listed)
- known peripheral arterial occlusive disease, patients without swan ganz catheter insertion, heart transplantation, infective endocarditis, emergency surgery, hemodynamic instability requiring vasopressor, preoperative lactate > 2mmol/L, known liver cirrhosis, pregnant, cognitive dysfunction, being unable to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of skin perfusion pressure
Time frame: From post induction to 6 hours
1 secondary outcome
Assessment of arterial lactate level
Time frame: From post induction to 48 hours
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 29 Apr 2016.
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?
An observational study of Peripheral Circulation During On-pump Cardiac Surgery, 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 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: finished, as of the sponsor's last update on 29 Apr 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Assessment of skin perfusion pressure (time frame: From post induction to 6 hours). 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 29 Apr 2016.