Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery

Cardiac Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713166
• Other study ID #: YSJeon_crystalloid vs colloid
• Status: Completed
• Phase: N/A
• First received: October 21, 2012
• Last updated: June 15, 2016
• Start date: March 2013
• Est. completion date: August 2014

Study information

• Verified date: June 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects of crystalloid and colloid, which are used for pump priming solution, on the microcirculatory alterations during cardiac surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Off-pump Coronary Artery Bypass Surgery

Exclusion Criteria:

• Infection

• Postoperative use of steroid

• Liver cirrhosis, Child-Pugh C

• Renal disease on hemodialysis

• Patients who cannot receive vascular occlusion test (severe peripheral vascular disease, arteriovenous fistula, burn)

• EF < 40% on the preoperative echocardiography

• Preoperative use of vasopressors or inotropic agents

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:
• plasmalyte solution
plasmalyte solution
• Hextend
Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery slope	Recovery slope is a marker of microcirculation. The tissue oxygen saturation (StO2) using InspectraTM StO2 (Hutchinson Technology Inc.,USA) will be recorded continuously. The InspectraTM StO2 probe will be placed on the skin of the thenar eminence and the blood pressure cuff will be wrapped around the arm. After performing vascular occlusion test, the recovery slope will be calculated by the software.	until 2 days after surgery	Yes
Primary	syndecan-1	marker of glycocalyx degradation	until 2 days after surgery	Yes
Secondary	lactate		until 2 days after surgery	No
Secondary	StO2 (tissue oxygen saturation)		until 2 days after surgery	Yes
Secondary	Cytokine	Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a	until 2 days after surgery	No