Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

NCT02831270 | Completed DMC

• 1 other identifier: KUH1160004-1
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Mitral Regurgitation; Mitral Stenosis; Tricuspid Regurgitation

Keywords

cardiac surgery; acute normovolemic hemodilution

Outcome Measures

Primary Outcomes (1)

• serum creatinine (s-Cr) concentration

  before ANH

Study Arms (2)

Control Group

Patients undergoing cardiac surgery supposed not to get acute normovolemic hemodilution (ANH) before CPB

Active Comparator: Acute normovolemic hemodilution group

Patients undergoing cardiac surgery supposed to get aucte normovolemic hemodilution (ANH) before CPB

Procedure: Acute normovolemic hemodilution (ANH); Drug: hydroxyethyl starch (HES 130/0.6)

Interventions

Acute normovolemic hemodilution (ANH) PROCEDURE

Active Comparator: Acute normovolemic hemodilution group

hydroxyethyl starch (HES 130/0.6) DRUG

Active Comparator: Acute normovolemic hemodilution group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgery due to valvular heart disease

You may qualify if:

• patients undergoing cardiac surgery with cardiopulmonary bypass who signed written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Stenosis; Tricuspid Valve Insufficiency

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: July 13, 2016
• Study Start: December 1, 2011
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

KR (1)