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Completed

NCT Number: NCT01713166

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

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.

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Key information

Conditions

Cardiac Surgery

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

plasmalyte solution

Drug

plasmalyte solution

Hextend

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.

Primary outcomes

  1. Recovery slope

    Time frame: 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.

  2. syndecan-1

    Time frame: until 2 days after surgery

    marker of glycocalyx degradation

Secondary outcomes

  1. lactate

    Time frame: until 2 days after surgery

  2. StO2 (tissue oxygen saturation)

    Time frame: until 2 days after surgery

  3. Cytokine

    Time frame: until 2 days after surgery

    Interleukin (IL)-1b, IL-6, IL-8, IL-10, TNF-a

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 24, 2012
Registry last updated
Jun 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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