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

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

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

Study Overview

• Status: Unknown
• Conditions: Colon Surgery
• Intervention / Treatment: Drug: Intravenous HES; Drug: Intravenous Crystalloid

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Konkuk University Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 11, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 12, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: blood viscosity; Colon Surgery
• Other Study ID Numbers: KUH000013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No