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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02700607
Other study ID # KUH1160101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date June 2017

Study information

Verified date July 2019
Source Konkuk University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing interventional cerebral aneurysm coiling procedure are enrolled in this prospective study and randomly allocated into one of two groups: Group-C (n=10) and Group-HES (n=10).

All recruited patients will be given patient identification number (PIN) for the present study of 01-20 according to their order of interview and recruitment. Investigators will prepare 10 yellow and 10 green cards, which will be inserted in 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 20 (Envelop number). After printing the envelope number outside envelope, all sealed envelopes with cards will be conveyed to and kept in pharmacy department.

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 20th patient's discharge and data acquisition


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing coiling embolization procedure due to cerebral aneurysm

- 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Konkuk University Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary whole blood viscosity whole blood viscosity measured by viscometer cm-1 with 1 hour after the completion of procedure
Secondary PaO2/FiO2 ratio PaO2/FiO2 ratio measured by arterial blood gas analysis 1 hour after the completion of procedure
Secondary hematocrit serum hematocrit, % 1 hour after the completion of procedure
Secondary glucose serum glucose level, g/dl 1 hour after the completion of procedure
Secondary osmolarity serum osmolarity, mosm 1 hour after the completion of procedure
Secondary urine output hourly urine output, ml/hr 1 hour after the completion of procedure
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