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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01713166

Enrollment

120

Registered

2012-10-24

Start date

2013-03-31

Completion date

2014-08-31

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery

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.

Interventions

DRUGplasmalyte solution

plasmalyte solution

DRUGHextend

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.
syndecan-1	until 2 days after surgery	marker of glycocalyx degradation

Secondary

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026