The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients
| Registry | NCT07329660, acronym CHAIN-T |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 116 (Estimated) |
| Sponsor | Air Force Military Medical University, China (Other) |
| Conditions | Transcatheter Aortic Valve Replacement, Hemodynamic Stability, Anesthesia Induction |
| Interventions | Hydroxyethyl starch 130/0.4, Lactate Ringer's Solution (Drug) |
| Dates | start 2026-02-16 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-01-09, last updated 2026-02-27 |
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All trials for Transcatheter Aortic Valve Replacement All trials for Hemodynamic Stability All trials of Hydroxyethyl starch 130/0.4 All trials of Lactate Ringer's Solution
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Colloid | Experimental | Drug: Hydroxyethyl starch 130/0.4 | 5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection. |
| Crystalloid | Active comparator | Drug: Lactate Ringer's Solution | 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Age ≥ 18 years; * Patients scheduled to undergo elective TAVR under general anesthesia; Exclusion Criteria: * Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy; * Severe cardiac dysfunction (ejection fraction\[EF\] < 35%); * Severe renal dysfunction (creatinine > 132 μg/L and/or requiring renal replacement therapy); * Morbid obesity (body mass index\[BMI\] > 37.5 kg/m² or > 32.5 kg/m² with metabolic diseases); * Severe hepatic dysfunction ; * Severe electrolyte disturbances ; * Patients with preoperative intracranial hypertension requiring dehydration therapy; * Expected postoperative hospital stay < 24 hours; * Patients scheduled for multiple surgeries during this hospitalization.