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

Not Applicable

• Conditions: Colon Surgery
• Interventions: Drug: Intravenous HES; Drug: Intravenous Crystalloid

• Registration Number: NCT02770027
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-12
• Last Update Posted: 2020-01-14
• Study Start: 2020-09
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
whole blood viscosity	with 1 hour after the completion of procedure	whole blood viscosity measured by viscometer cm-1

Secondary Outcome Measures

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