Impact of Intravascular Fluid Resuscitation and Whole Blood Viscosity

NCT02700607 | Completed DMC

• 1 other identifier: KUH1160101
• Study Type: interventional
• Target: 40
• 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 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

Conditions

Cerebral Aneurysm

Keywords

cerebral aneurysm, coiling embolization, 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 (5)

• 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 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

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

Related Publications (1)

• Oh CS, Kim JD, Kwon WK, Lee S, Kang H, Kim TY. Impact of Intravascular Fluid Resuscitation on Whole Blood Viscosity During Endovascular Detachable Coiling Procedure for Unruptured Intracranial Aneurysm: A Prospective Randomized Controlled Trial. J Korean Med Sci. 2025 Nov 17;40(44):e287. doi: 10.3346/jkms.2025.40.e287.

  PMID: 41250652 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

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: February 23, 2016
• First Posted: March 7, 2016
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: September 19, 2024

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share