Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity for Colon Surgery

Study Overview
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Brief Summary
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After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing colon surgery are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=15) and Group-HES (n=15). All recruited patients will be given patient identification number (PIN) for the present study of 01-30 according to their order of interview and recruitment. Investigators will prepare 15 yellow and 15 green cards, which will be inserted in 30 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (Envelop number). According to the color of the card, attending anesthesiologists will give crystalloid for yellow card or HES for green cards, respectively, to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture. Patient data and statistical analyses: Patient's data whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be determined from the patients' medical record after patient's discharge. All statistical analyses will be performed after the 30th patient's discharge and data acquisition

Official Title
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Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Colon Surgery

Conditions
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Colon Surgery

Intervention / Treatment
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* Drug: Intravenous Crystalloid
* Drug: Intravenous HES


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing colon surgery Patients provided a written informed consent. Patients with preoperative serum hemoglobin concentration >13 g/dL (male) and >12 g/dL (female) Patients with PaO2/FiO2 ratio >150 Exclusion Criteria: Patients with history of anemia, dyspnea, active infection. Patients with endocrine disease Patients received or receiving intraoperative and preoperative blood salvaged, allogenic blood transfusion, anti-platelet drug, anti-fibrinolytic agents or recombinant human erythropoietin, or undergoing acute normovolemic hemodilution.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Intravenous Crystalloid<br>Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture | Drug: Intravenous Crystalloid<br>* Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture<br>|
| Active Comparator: Intravenous HES<br>HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture | Drug: Intravenous HES<br>* HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| whole blood viscosity | whole blood viscosity measured by viscometer cm-1 | with 1 hour after the completion of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 ratio | PaO2/FiO2 ratio measured by arterial blood gas analysis | 1 hour after the completion of procedure | 
| hematocrit | serum hematocrit, % | 1 hour after the completion of procedure | 
| glucose | serum glucose level, g/dl | 1 hour after the completion of procedure | 
| osmolarity | serum osmolarity, mOsm | 1 hour after the completion of procedure | 
| urine output | hourly urine output, ml/hr | 1 hour after the completion of procedure | 
| Maximum clot formation | Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm | 1 hour after the completion of procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Surgery, blood viscosity