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

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ClinicalTrials.gov Identifier: NCT02770027
Recruitment Status : Unknown
Verified May 2016 by Tae-Yop Kim, MD PhD, Konkuk University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Tae-Yop Kim, MD PhD, Konkuk University Medical Center

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Colon Surgery Drug: Intravenous Crystalloid Drug: Intravenous HES Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Colon Surgery
Study Start Date : May 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : January 2017

Arm Intervention/treatment
Placebo Comparator: Intravenous Crystalloid
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
Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

Active Comparator: Intravenous HES
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
HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture




Primary Outcome Measures :
  1. whole blood viscosity [ Time Frame: with 1 hour after the completion of procedure ]
    whole blood viscosity measured by viscometer cm-1


Secondary Outcome Measures :
  1. PaO2/FiO2 ratio [ Time Frame: 1 hour after the completion of procedure ]
    PaO2/FiO2 ratio measured by arterial blood gas analysis

  2. hematocrit [ Time Frame: 1 hour after the completion of procedure ]
    serum hematocrit, %

  3. glucose [ Time Frame: 1 hour after the completion of procedure ]
    serum glucose level, g/dl

  4. osmolarity [ Time Frame: 1 hour after the completion of procedure ]
    serum osmolarity, mOsm

  5. urine output [ Time Frame: 1 hour after the completion of procedure ]
    hourly urine output, ml/hr

  6. Maximum clot formation [ Time Frame: 1 hour after the completion of procedure ]
    Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770027


Contacts
Contact: Tae-Yop Kim, MD, PhD 82-2-2030-5448 taeyop@gmail.com

Sponsors and Collaborators
Konkuk University Medical Center

Responsible Party: Tae-Yop Kim, MD PhD, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02770027     History of Changes
Other Study ID Numbers: KUH000013
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Tae-Yop Kim, MD PhD, Konkuk University Medical Center:
Colon Surgery
blood viscosity

Additional relevant MeSH terms:
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents