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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02757118
• Other study ID #: KUH000011
• Status: Not yet recruiting
• Phase: N/A
• First received: April 27, 2016
• Last updated: April 27, 2016
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2016
• Source: Konkuk University Medical Center
• Contact: Tae-Yop Kim, MD, PhD
• Phone: 82-2-2030-5448
• Email: taeyop[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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
• Intravenous HES
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	whole blood viscosity		with 1 hour after the completion of procedure	No
Secondary	PaO2/FiO2 ratio	PaO2/FiO2 ratio measured by arterial blood gas analysis	with 1 hour after the completion of procedure	No
Secondary	hematocrit	serum hematocrit, %	with 1 hour after the completion of procedure	No
Secondary	glucose	serum glucose level, g/dl	with 1 hour after the completion of procedure	No
Secondary	osmolarity	serum osmolarity, mOsm	with 1 hour after the completion of procedure	No
Secondary	urine output	hourly urine output, ml/hr	with 1 hour after the completion of procedure	No
Secondary	Maximum clot formation	Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm	with 1 hour after the completion of procedure	No