Clinical trial NCT03366753: Impact of Acute Normovolemic Hemodilution on Blood Viscosity
Official title: Impact of Intravascular Fluid Resuscitation for Acute Normovolemic Hemodilution on Blood Viscosity and Oxygen Delivery in Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Keywords: acute normovolemic hemodilution
coronary artery bypass graft surgery
hydroxyethyl starch
blood viscosity
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Acute normovolemic hemodilution consists of phlebotomy and intravascular volume resuscitation by using crystalloid/colloid in a same amount of phlebotomy
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* patients undergoing off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Preoperative anemia
* LV ejection fraction \< 50%

Primary outcomes:
measure: blood viscosity at shear rate 5/sec
timeFrame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
measure: hematocrit/blood viscosity at 5/sec
timeFrame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Secondary outcomes:
measure: blood viscosity at shear rate 300/sec
timeFrame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
measure: Hematocrit/viscosity at shear rate 300/sec
timeFrame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
measure: Coagulation profiles in ROTEM
timeFrame: 5 min after acute normovoelmic hemodilution, 5 min after in-vitro dilution
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Tae-Yop Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: