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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colloid | Experimental | 5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection. |
|
| Crystalloid | Active Comparator | 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxyethyl starch 130/0.4 | Drug | 5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | induction period, at an average of 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 15 minutes after induction | |
| Intraoperative use of vasoactive drugs. | Intraoperative period, at an average of 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihong Lu | Contact | 86-13891975018 | deerlu23@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hailong Dong | Air Force Medical University | Study Chair |
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| ID | Term |
|---|---|
| D006895 | Hydroxyethyl Starch Derivatives |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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| Lactate Ringer's Solution | Drug | 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. |
|
| 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. | The first postoperative day, at 24 hours after surgery |
| Length of hospital stay. | 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 | During the postoperative period prior to discharge (at an average of 5 days) |
| In-hospital all-cause mortality | During the postoperative period prior to discharge (at an average of 5 days) |
| All-cause mortality within 30 days postoperatively | 30 days after surgery |
| Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period | 30 days after surgery |
| D011134 |
| Polysaccharides |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |