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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01713166
First received: October 21, 2012
Last updated: June 7, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Cardiac Surgery
Drug: plasmalyte solution
Drug: Hextend

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Recovery slope [ Time Frame: until 2 days after surgery ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: until 2 days after surgery ] [ Designated as safety issue: Yes ]
    marker of glycocalyx degradation


Secondary Outcome Measures:
  • lactate [ Time Frame: until 2 days after surgery ] [ Designated as safety issue: No ]
  • StO2 (tissue oxygen saturation) [ Time Frame: until 2 days after surgery ] [ Designated as safety issue: Yes ]
  • Cytokine [ Time Frame: until 2 days after surgery ] [ Designated as safety issue: No ]
    Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a


Enrollment: 120
Study Start Date: March 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Valvular heart 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01713166

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yunseok Jeon, Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01713166     History of Changes
Other Study ID Numbers: YSJeon_crystalloid vs colloid
Study First Received: October 21, 2012
Last Updated: June 7, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Pharmaceutical Solutions
Plasma-lyte 148
Ophthalmic Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015