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Completed

NCT Number: NCT02700607

Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

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=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 20 thick-paper envelopes. Then, all envelopes will be sealed, mixed and randomly allocated to get numbers of 01 to 30 (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 lesser than 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture.

Patient data and statistical analyses:

Patients demographic data, whole blood viscosity, PaO2, FiO2, Hemoglobin, urine amount, s-glucose will be obtained

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 HES

Drug

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

Primary outcomes

  1. whole blood viscosity

    Time frame: with 1 hour after the completion of procedure

    whole blood viscosity measured by viscometer cm-1

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Coiling Embolization Procedure for Cerebral Artery Aneurysm

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 7, 2016
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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