Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients (CHAIN-T)

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Transcatheter Aortic Valve Replacement; Anesthesia Induction; Hemodynamic Stability

Treatments: Drug: Hydroxyethyl starch 130/0.4; Drug: Lactate Ringer's Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07329660

XJH-A-20250824

Details and patient eligibility

About

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).

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups

Colloid

Experimental group

Description:

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

Treatment:

Drug: Hydroxyethyl starch 130/0.4

Crystalloid

Active Comparator group

Description:

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

Treatment:

Drug: Lactate Ringer's Solution