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

NCT02770027 | Unknown

• 1 other identifier: KUH000013
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Colon Surgery

Keywords

Colon Surgery; blood viscosity

Outcome Measures

Primary Outcomes (1)

• whole blood viscosity

  whole blood viscosity measured by viscometer cm-1

  with 1 hour after the completion of procedure

Secondary Outcomes (6)

• PaO2/FiO2 ratio

  1 hour after the completion of procedure

• hematocrit

  1 hour after the completion of procedure

• glucose

  1 hour after the completion of procedure

• osmolarity

  1 hour after the completion of procedure

• urine output

  1 hour after the completion of procedure

Study Arms (2)

Intravenous Crystalloid

PLACEBO COMPARATOR

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

Intravenous HES

ACTIVE COMPARATOR

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

Interventions

Intravenous Crystalloid DRUG

Crystalloid is administered to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture

Intravenous Crystalloid

Intravenous HES DRUG

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

Intravenous HES

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Konkuk University Medical Center: lead

Central Study Contacts

Tae-Yop Kim, MD, PhD

CONTACT

82-2-2030-5448; taeyop@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share