Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery
NCT ID: NCT02831270
Last Updated: 2016-07-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
32 participants
OBSERVATIONAL
2011-12-31
2016-06-30
Brief Summary
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In patients undergoing cardiac surgery employing moderate hypothermic CPB (age 20-71 years, n=32), ANH will be randomly applied to 15 patients (Group-ANH) but not in 17 patients (Group-C) before initiating CPB. For ANH procedure consisting of 5 ml/kg of blood salvage and administering 5 ml/kg of balanced hydroxyethyl starch (HES) 130/0.4 for 15 min will be started at 30 min after anesthesia induction and before CPB application for surgery. In both groups, moderate hypothermic CPB will be initiated by using 1600-1800 ml of bloodless priming solution. The changes of hematocrit (Hct), Na+, K+, HCO3-, Ca2+, osmolarity, s-Cr will be determined before ANH (T1), after the first ANH of 2.5 ml/kg (T2), and after the second ANH of 2.5 ml/kg (T3), 30 sec and 60 sec after the initiation of CPB (T4, T5), immediately and 1 hour after the weaning from CPB (T6, T7) and at the end of surgery (T8). S-Cr will be determined by using a point-of-care test device (StatSensor™ Creatinine, Nova Biomedical, USA).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control Group
Patients undergoing cardiac surgery supposed not to get acute normovolemic hemodilution (ANH) before CPB
No interventions assigned to this group
Active Comparator: Acute normovolemic hemodilution group
Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Acute normovolemic hemodilution (ANH)
hydroxyethyl starch (HES 130/0.6)
Interventions
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Acute normovolemic hemodilution (ANH)
hydroxyethyl starch (HES 130/0.6)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* preoperative liver disease
* preoperative low cardiac output (EF \< 50%)
* Preoperative IABP application, Atrial fibrillation, Pacemaker,
* contraindication for applying TEE
* intraoperative withdrawal
19 Years
65 Years
ALL
No
Sponsors
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Konkuk University Medical Center
OTHER
Responsible Party
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Tae-Yop Kim, MD PhD
Professor of Anesthesiology
Locations
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Konkuk University Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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KUH1160004-1
Identifier Type: -
Identifier Source: org_study_id
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