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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Drug: plasmalyte solution; Drug: Hextend

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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
Active Comparator: Plasmalyte solution; Plasmalyte solution infusion to meet the fluid requirements.	Drug: plasmalyte solution; plasmalyte solution
Experimental: Hextend; 6% Hetastarch administeration 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
syndecan-1	marker of glycocalyx degradation	until 2 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lactate		until 2 days after surgery
StO2 (tissue oxygen saturation)		until 2 days after surgery
Cytokine	Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a	until 2 days after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 21, 2012
• First Submitted That Met QC Criteria: October 21, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: YSJeon_crystalloid vs colloid