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

Not Applicable

Completed

• Conditions: Cardiac Surgery
• Interventions: Drug: plasmalyte solution; Drug: Hextend

• Registration Number: NCT01713166
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2012-10-21
• Study First Submitted QC: 2012-10-21
• Study First Posted: 2012-10-24
• Study Start: 2013-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-15
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Off-pump Coronary Artery Bypass Surgery

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasmalyte solution	plasmalyte solution	Plasmalyte solution infusion to meet the fluid requirements.
Hextend	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.

Primary Outcome Measures

Name	Time	Method
syndecan-1	until 2 days after surgery	marker of glycocalyx degradation
Recovery slope	until 2 days after surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of