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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Yunseok Jeon, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01713166
First received: October 21, 2012
Last updated: May 13, 2014
Last verified: May 2014
  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: Lactated Ringer's solution
Drug: Volulyte
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.

  • 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.


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


Estimated Enrollment: 93
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lactated Ringer's solution
Lactated Ringer's solution of 1500 ml will be used as a pump-priming solution during cardiac surgery.
Drug: Lactated Ringer's solution
Lactated Ringer's solution of 1500 ml will be used as a pump-priming solution during cardiac surgery.
Experimental: Volulyte
Lactated Ringer's solution of 500 ml with Hydroxyethyl Starch 6% 130/0.4 (Volulyte, Fresenius Kabi, Germany) of 1000 ml will be used as a pump-priming solution during cardiac surgery.
Drug: Volulyte
Lactated Ringer's solution of 500 ml with Hydroxyethyl Starch 6% 130/0.4 (Volulyte, Fresenius Kabi, Germany) of 1000 ml will be used as a pump-priming solution during cardiac surgery.
Experimental: Hextend
Lactated Ringer's solution of 500 ml with Hextend (BioTime Inc., Berkerley, CA) of 1000 ml will be used as a pump-priming solution during cardiac surgery.
Drug: Hextend
Lactated Ringer's solution of 500 ml with Hextend (BioTime Inc., Berkerley, CA) of 1000 ml will be used as a pump-priming solution during cardiac surgery.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713166

Contacts
Contact: Yunseok Jeon, PhD 82-2-2072-2467 jeonyunseok@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yunseok Jeon, PhD    82-2-2072-2467    jeonyunseok@gmail.com   
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: May 13, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014