Acute Normovolemic Hemodilution on Serum-creatinine Concentration in Cardiac Surgery

July 10, 2016 updated by: Tae-Yop Kim, MD PhD, Konkuk University Medical Center

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

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).

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Completed

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Observational

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32

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Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective cardiac surgery due to valvular heart disease

Description

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

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Group / Cohort

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Intervention / Treatment

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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)

What is the study measuring?

Primary Outcome Measures

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Outcome Measure
Time Frame
serum creatinine (s-Cr) concentration
Time Frame: before ANH
before ANH

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Konkuk University Medical Center

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December 1, 2011

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June 1, 2016

Study Completion (ACTUAL)

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June 1, 2016

Study Registration Dates

First Submitted

First Submitted

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July 10, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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July 10, 2016

First Posted (ESTIMATE)

First Posted

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July 13, 2016

Study Record Updates

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July 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

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Other Study ID Numbers

Other Study ID Numbers

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  • KUH1160004-1

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