An interventional study of Intravenous Crystalloid and Intravenous HES in Cardiac Surgery, sponsored by Konkuk University Medical Center. Status unknown. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-29.
Sponsored by Konkuk University Medical Center · Not applicable, Interventional, and Treatment
After obtaining approval from the Institutional Review Board of our institution, written informed consent is obtained from patients undergoing cardiac 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). 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 30th patient's discharge and data acquisition
Konkuk University Medical Center is the lead sponsor of 93 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
crystalloid is administered to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
HES is administered to maintain stroke volume variation \< 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
whole blood viscosity
Time frame: with 1 hour after the completion of procedure
PaO2/FiO2 ratio
PaO2/FiO2 ratio measured by arterial blood gas analysis
Time frame: with 1 hour after the completion of procedure
hematocrit
serum hematocrit, %
Time frame: with 1 hour after the completion of procedure
glucose
serum glucose level, g/dl
Time frame: with 1 hour after the completion of procedure
osmolarity
serum osmolarity, mOsm
Time frame: with 1 hour after the completion of procedure
urine output
hourly urine output, ml/hr
Time frame: with 1 hour after the completion of procedure
Maximum clot formation
Maximum clot formation in rotational thromboelastometry (ROTEM) analysis, mm
Time frame: with 1 hour after the completion of procedure
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Konkuk University Medical Center