The purpose of this study is to evaluate whether the administration of 5 ml/kg of colloid solution prior to anesthesia induction, compared with 5 ml/kg of lactated Ringer's solution, can reduce hemodynamic fluctuations during the induction period (defined as the first 15 minutes after induction) in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
116
5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.
5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.
The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period.
The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5…15), and ΔX is the time interval between measurements.
Time frame: induction period, at an average of 15 minutes
Incidence of post-induction hemodynamic instability, defined as arterial pressure (MAP)< 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction.
Time frame: 15 minutes after induction
Intraoperative use of vasoactive drugs.
Time frame: Intraoperative period, at an average of 2 hours
Sequential Organ Failure Assessment(SOFA )score on the first postoperative day
SOFA score grades organ dysfunction from 0 (normal) to 4 (most abnormal) for six organ systems . The total score is the sum of all six sub-scores, ranging from 0 to 24 . The higher score means the worse organ function.
Time frame: The first postoperative day, at 24 hours after surgery
Length of hospital stay.
Time frame: The duration of the patient's hospitalization after the initial surgery, at an average of 5 days.
Proportion of patients admitted to the intensive care unit (ICU) after surgery
Time frame: During the postoperative period prior to discharge (at an average of 5 days)
In-hospital all-cause mortality
Time frame: During the postoperative period prior to discharge (at an average of 5 days)
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All-cause mortality within 30 days postoperatively
Time frame: 30 days after surgery
Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period
Time frame: 30 days after surgery