Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery
1 other identifier
interventional
120
1 country
1
Brief Summary
The purpose of this study is to compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
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
First Submitted
Initial submission to the registry
October 21, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 16, 2016
June 1, 2016
1.4 years
October 21, 2012
June 15, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Recovery slope
Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software.
until 2 days after surgery
syndecan-1
marker of glycocalyx degradation
until 2 days after surgery
Secondary Outcomes (3)
lactate
until 2 days after surgery
StO2 (tissue oxygen saturation)
until 2 days after surgery
Cytokine
until 2 days after surgery
Study Arms (2)
Plasmalyte solution
ACTIVE COMPARATORPlasmalyte solution infusion to meet the fluid requirements.
Hextend
EXPERIMENTAL6% Hetastarch administeration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.
Interventions
Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.
Eligibility Criteria
You may qualify if:
- Off-pump Coronary Artery Bypass Surgery
You may not qualify if:
- Infection
- Postoperative use of steroid
- Liver cirrhosis, Child-Pugh C
- Renal disease on hemodialysis
- Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn)
- EF \< 40% on the preoperative echocardiography
- Preoperative use of vasopressors or inotropic agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 21, 2012
First Posted
October 24, 2012
Study Start
March 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
June 16, 2016
Record last verified: 2016-06