Effect of Prewarming on Microcirculatory Response
1 other identifier
interventional
40
1 country
1
Brief Summary
Intraoperative hypothermia may affect tissue microcirculation and can induce myocardial injury, wound infection, and coagulopathy. During off-pump coronary artery bypass surgery without cardiopulmonary bypass or induced hypothermia, maintenance of normothermia is important for clinical outcome. The investigators hypothesized that prewarming during induction of general anesthesia would reduce drop of body temperature and change of peripheral microcirculation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
October 29, 2018
CompletedMarch 18, 2019
August 1, 2014
10 months
July 4, 2014
March 2, 2017
February 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recovery Slope
We will compare recovery slope assessed 3 hours after induction of anesthesia to evaluate the effect of prewarming during induction of anesthesia on microcirculation.
3 hours after induction of anesthesia
Secondary Outcomes (1)
Tissue Oxygen Saturation
During the surgery, an average of 4 hours
Study Arms (2)
prewarming
EXPERIMENTALprewarming during induction of anesthesia
control
NO INTERVENTIONno prewarming during induction of anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- off-pump coronary artery bypass surgery
You may not qualify if:
- refuse to enroll
- cannot undergo vascular occlusion test: anatomical abnormality of both arms, severe peripheral vascular disease, presence of A-V fistula
- preoperative left ventricular ejection fraction \< 35%
- preoperative continuous infusion of vasopressor or inotropes
- pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
Cho YJ, Lee SY, Kim TK, Hong DM, Jeon Y. Effect of Prewarming during Induction of Anesthesia on Microvascular Reactivity in Patients Undergoing Off-Pump Coronary Artery Bypass Surgery: A Randomized Clinical Trial. PLoS One. 2016 Jul 21;11(7):e0159772. doi: 10.1371/journal.pone.0159772. eCollection 2016.
PMID: 27442052DERIVED
Results Point of Contact
- Title
- Dr Yunseok Jeon
- Organization
- Seoul National University Hospital Dept of Anesthesiology
Study Officials
- PRINCIPAL INVESTIGATOR
Yunseok Jeon, PhD
Seoul National University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 10, 2014
Study Start
July 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 18, 2019
Results First Posted
October 29, 2018
Record last verified: 2014-08
Data Sharing
- IPD Sharing
- Will not share