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

NCT ID: NCT01713166

Last Updated: 2016-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2014-08-31

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.

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Plasmalyte solution

Plasmalyte solution infusion to meet the fluid requirements.

Group Type: ACTIVE_COMPARATOR

plasmalyte solution

Intervention Type: DRUG

plasmalyte solution

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.

Group Type: EXPERIMENTAL

Hextend

Intervention Type: DRUG

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.

Interventions

plasmalyte solution

plasmalyte solution

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yunseok Jeon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YSJeon_crystalloid vs colloid

Identifier Type: -

Identifier Source: org_study_id