Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

Mitral Regurgitation Clinical Trial

Official title:

Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831270
• Other study ID #: KUH1160004-1
• 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 (StatSensor™ 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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Stenosis
• Mitral Valve Insufficiency
• Mitral Valve Stenosis
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

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