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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02831270
Other study ID # KUH1160004-1
Secondary ID
Status Completed
Phase N/A
First received July 10, 2016
Last updated July 10, 2016
Start date December 2011
Est. completion date June 2016

Study information

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

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Acute normovolemic hemodilution (ANH)

Drug:
hydroxyethyl starch (HES 130/0.6)


Locations

Country Name City State
Korea, Republic of Konkuk University Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum creatinine (s-Cr) concentration before ANH No
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