Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-04

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Transcatheter Aortic Valve Replacement Hemodynamic Stability Anesthesia Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Colloid

5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection.

Group Type EXPERIMENTAL

Hydroxyethyl starch 130/0.4

Intervention Type DRUG

5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.

Crystalloid

5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Group Type ACTIVE_COMPARATOR

Lactate Ringer's Solution

Intervention Type DRUG

5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Interventions

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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.

Intervention Type DRUG

Lactate Ringer's Solution

5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No