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Not yet recruiting NCT07329660

Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

No phase Interventional Transcatheter Aortic Valve Replacement Hemodynamic Stability Anesthesia Induction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hydroxyethyl starch 130/0.4, Lactate Ringer's Solution.
Who it may be relevant to
Registry conditions: Transcatheter Aortic Valve Replacement, Hemodynamic Stability, Anesthesia Induction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients

Overview

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).

Interventions

  • Drug Hydroxyethyl starch 130/0.4
    5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.
  • Drug Lactate Ringer's Solution
    5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Primary outcome measures

  • The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period. [Time frame: induction period, at an average of 15 minutes]
Secondary outcome measures (8)
  • 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 [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)]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07329660 · XJH-A-20250824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗