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Clinical Trials/NCT03366753
NCT03366753CompletedNot Applicable

Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery

Konkuk University Medical Center1 site in 1 country21 target enrollmentStarted: May 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
blood viscosity at shear rate 5/sec

Study Overview

Brief Summary

Acute normovolemic hemodilution (ANH) has long been employed for reducing allogenic blood transfusion for cardiac surgery, and hydroxyethyl starch has been used as an intravenous replacement fluid during ANH procedure. However, possible impact of ANH employing HES on blood viscosity and oxygen delivery have not been well investigated in patients undergoing off-pump coronary artery bypass (OPCAB) surgery .

Anesthesia is induced and maintained by using propofol-remifentanil-rocuronium in OPCAB surgery (n=21). ANH is performed by using 5 ml/kg of blood salvage and administering 5 ml/kg of balanced HES 130/0.42 (Tetraspan™) for 15 min during vascular graft harvesting. For the present study, three arterial blood samples (3 ml each) are taken before (Sample 1) and after ANH (sample 2 and 3) and they are stored in 3 tubes. Sample 3 (in tube) undergoes further 30% in-vitro dilution by adding 1-1.5 ml HES. By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at low shear rate (5/sec) of the three samples are determined. By using a formula with blood viscosity and hematocrit, tissue O2 delivery index (TODI, = hematocrit/viscosity at 5/sec) is calculated.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria

  • •Preoperative anemia
  • •LV ejection fraction < 50%

Arms & Interventions

Acute normovolemic hemodilution

Experimental

acute normovolemic hemodilution by using hydroxyethyl starch

Intervention: acute normovolemic hemodilution (Procedure)

Acute normovolemic hemodilution

Experimental

acute normovolemic hemodilution by using hydroxyethyl starch

Intervention: In-vitro hemodilution (Procedure)

In-vitro hemodilution

Experimental

adding additional hydroxyethyl starch for achieving further 30% dilution of whole blood sample which already underwent ANH of 4-6 ml/kg.

Intervention: In-vitro hemodilution (Procedure)

Outcomes

Primary Outcomes

blood viscosity at shear rate 5/sec

Time Frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 5/sec of the three samples are determined

hematocrit/blood viscosity at 5/sec

Time Frame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution

oxygen delivery index calculated with a formula (= hematocrit/blood viscosity)

Secondary Outcomes

  • blood viscosity at shear rate 300/sec(5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution)
  • Coagulation profiles in ROTEM(5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution)
  • Hematocrit/viscosity at shear rate 300/sec(5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tae-Yop Kim, MD PhD

Professor of Anesthesiology

Konkuk University Medical Center

Study Sites (1)

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