Mitral Regurgitation Clinical Trial
Official title:
Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?
Verified date | July 2016 |
Source | Konkuk University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Observational |
Serum-creatinine level (s-Cr) is an important factor for predicting perioperative patient's
outcome regarding acute kidney injury. Although cardiopulmonary bypass (CPB), an essential
procedure for cardiac surgery, dilutes patient's blood components, possible impact of
applying acute normovolemic hemodilution (ANH) and CPB on s-Cr has not been well
investigated.
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 (StatSensorâ„¢ Creatinine, Nova
Biomedical, USA).
Status | Completed |
Enrollment | 32 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years to 65 Years |
Eligibility |
Inclusion Criteria: - patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent Exclusion Criteria: - preoperative renal failure requiring reran replacement therapy - preoperative liver disease - preoperative low cardiac output (EF < 50%) - Preoperative IABP application, Atrial fibrillation, Pacemaker, - contraindication for applying TEE - intraoperative withdrawal |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Konkuk University Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Konkuk University Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | serum creatinine (s-Cr) concentration | before ANH | No |
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