Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

NCT07329660 | Not Yet Recruiting

• 1 other identifier: XJH-A-20250824
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Transcatheter Aortic Valve Replacement; Hemodynamic Stability; Anesthesia Induction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (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.

  15 minutes after induction

• Intraoperative use of vasoactive drugs.

  Intraoperative period, at an average of 2 hours

• Sequential Organ Failure Assessment(SOFA )score on the first postoperative day

  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)

Study Arms (2)

Colloid

EXPERIMENTAL

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

Drug: Hydroxyethyl starch 130/0.4

Crystalloid

ACTIVE COMPARATOR

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

Drug: Lactate Ringer's Solution

Interventions

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.

Colloid

Lactate Ringer's Solution DRUG

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

Crystalloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Patients scheduled to undergo elective TAVR under general anesthesia;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

MeSH Terms

Interventions

Hydroxyethyl Starch Derivatives; Ringer's Lactate

Intervention Hierarchy (Ancestors)

Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Hailong Dong

  Air Force Medical University

  STUDY CHAIR

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018; deerlu23@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: February 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02