Coronary Artery Disease Clinical Trial
Official title:
Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery
| Verified date | December 2021 |
| Source | Konkuk University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 21 |
| Est. completion date | November 30, 2018 |
| Est. primary completion date | November 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - patients undergoing off-pump coronary artery bypass graft surgery Exclusion Criteria: - Preoperative anemia - LV ejection fraction < 50% |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Konkuk University Medical Center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Konkuk University Medical Center |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood viscosity at shear rate 5/sec | By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 5/sec of the three samples are determined | 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution | |
| Primary | hematocrit/blood viscosity at 5/sec | oxygen delivery index calculated with a formula (= hematocrit/blood viscosity) | 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution | |
| Secondary | blood viscosity at shear rate 300/sec | By using a scanning capillary tube viscometer (Hemovister™), Blood viscosity at shear rate 300/sec of the three samples are determined | 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution | |
| Secondary | Hematocrit/viscosity at shear rate 300/sec | oxygen delivery index calculated with a formula (= hematocrit/blood viscosity) | 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution | |
| Secondary | Coagulation profiles in ROTEM | clot formation time in extem, MCF in extemA5 in fibtem, | 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution |
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