Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

Completed

• Conditions: Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation
• Interventions: Procedure: Acute normovolemic hemodilution (ANH); Drug: hydroxyethyl starch (HES 130/0.6)

• Registration Number: NCT02831270
• Lead Sponsor: Konkuk University Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Study First Submitted: 2016-07-10
• Study First Submitted QC: 2016-07-10
• Last Update Submitted: 2016-07-10
• Study First Posted: 2016-07-13
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Comparator: Acute normovolemic hemodilution group	Acute normovolemic hemodilution (ANH)	Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB
Active Comparator: Acute normovolemic hemodilution group	hydroxyethyl starch (HES 130/0.6)	Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB

Primary Outcome Measures

Name	Time	Method
serum creatinine (s-Cr) concentration	before ANH

Trial Locations

Locations (1)

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of