Clinical trial NCT03222778: Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery
Official title: Combination of Static Echocardiographic Indices for Prediction of Fluid Responsiveness During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Keywords: fluid responsiveness
tissue doppler
off-pump coronary bypass surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-07-19
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for off-pump coronary bypass surgery

Brief summary: In the perioperative or critical care of hemodynamically unstable patients, appropriate fluid resuscitation guided by reliable preload indices is of pivotal importance as only half of them are fluid responsive, and that empiric fluid administration actually leads to dismal prognosis. In the continuum of being non-invasive, combinations of tissue Doppler-derived parameters of early (e') and late (a') diastolic, and peak systolic velocity (s') of the mitral annulus provide information regarding the systolic dysfunction and preload (e'/s'), and LV stiffness (e'/a'). Although the left ventricular end-diastolic area (LVEDA) alone is not a valid predictor of fluid responsiveness, combining LVEDA with these indices would provide comprehensive information regarding the LV dimension, preload, and compliance as well as systolic function. Also, it seems logical to assume that patients with low LVEDA and high e' velocity indicating preserved early diastolic relaxation or low e (early mitral inflow velocity) /e' ratio indicating normal LV filling pressure would more likely be fluid responsive. Yet, these assumptions have not been tested before. Moreover, these values can be reliably obtained regardless of the heart rhythm, except for a', and do not completely rely on heart-lung interaction as opposed to the dynamic indices. Thus, the aim of this prospective trial is to investigate the role of LVEDA combined with e, e', a' or s' as a preload index in predicting fluid responsiveness in patients scheduled for off-pump coronary bypass surgery, in closed-chest conditions.


Eligibility criteria: Inclusion Criteria:

1. the patients scheduled for off-pump coronary bypass surgery
2. tha age ≥20 yrs old
3. the patients who are willing to provide written informed consent

Exclusion Criteria:

heart rhythm other than sinus, L, septal and/or lateral wall motion abnormalities, and a

1. New York Heart Association functional class ≥III
2. LV ejection fraction \<40%
3. emergency operation
4. the patients with preoperative septal and/or lateral wall motion abnormalities
5. contraindications to transesophageal echocardiography or balanced 6% hydroxyethyl starch 130/0.4
6. the patients with any valvular heart disease ≥moderate degree
7. No communication possible due to a language barrier or deafness

Primary outcomes:
measure: Predictive ability of combined echocardiographic index consisting of LVEDA, e, e', s' or a'
timeFrame: 15 to 20 min after anesthetic induction during closed chest condition
Secondary outcomes:
measure: Comparison between the combine echocardiographic index and LVEDA alone, CVP, PCWP, RVEDV and PPV for the predictive ability on fluid responsiveness
timeFrame: 15 to 20 min after anesthetic induction during closed chest condition
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine
Study officials:
References: