Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Cardiac Surgery

Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Cardiac Surgery

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing cardiac surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15).

All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.

According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge.

All statistical analyses will be performed after the 30th patient's discharge and data acquisition

Study Overview

• Status: Unknown
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: Intravenous Crystalloid; Drug: Intravenous HES

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients undergoing coiling embolization procedure due to cardiac surgery
• Patients provided a written informed consent.
• Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female)
• Patients with PaO2/FiO2 ratio >150

Exclusion Criteria:

• Patients with history of anemia, dyspnea, active infection.
• Patients with endocrine disease
• Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing cardiac surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Intravenous Crystalloid; crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture	Drug: Intravenous Crystalloid; crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
ACTIVE_COMPARATOR: Intravenous HES; HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture	Drug: Intravenous HES; HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
whole blood viscosity	with 1 hour after the completion of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PaO2/FiO2 ratio	PaO2/FiO2 ratio measured by arterial blood gas analysis	with 1 hour after the completion of procedure
hematocrit	serum hematocrit, %	with 1 hour after the completion of procedure
glucose	serum glucose level, g/dl	with 1 hour after the completion of procedure
osmolarity	serum osmolarity, mOsm	with 1 hour after the completion of procedure
urine output	hourly urine output, ml/hr	with 1 hour after the completion of procedure
Maximum clot formation	Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm	with 1 hour after the completion of procedure

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): October 1, 2016
• Study Completion (ANTICIPATED): January 1, 2017

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 27, 2016
• First Posted (ESTIMATE): April 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac Surgery, blood viscosity
• Other Study ID Numbers: KUH000011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO