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Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT02831270
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, 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).


Condition or disease Intervention/treatment
Mitral Regurgitation Mitral Stenosis Tricuspid Regurgitation Procedure: Acute normovolemic hemodilution (ANH) Drug: hydroxyethyl starch (HES 130/0.6)

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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Does Acute Normovolemic Hemodilution Affect Intraoperative Value of Serum-creatinine Concentration in Patients Undergoing Cardiac Surgery?
Study Start Date : December 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)



Primary Outcome Measures :
  1. serum creatinine (s-Cr) concentration [ Time Frame: before ANH ]


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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing elective cardiac surgery due to valvular heart disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831270


Locations
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Korea, Republic of
Konkuk University Medical Center
Seoul, Korea, Republic of, 143-729
Sponsors and Collaborators
Konkuk University Medical Center

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Responsible Party: Tae-Yop Kim, MD PhD, Professor of Anesthesiology, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02831270    
Other Study ID Numbers: KUH1160004-1
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2016
Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
cardiac surgery
acute normovolemic hemodilution
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Tricuspid Valve Insufficiency
Mitral Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases