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NCT Number: NCT07329660

Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

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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Key information

Conditions

Transcatheter Aortic Valve Replacement Anesthesia Induction Hemodynamic Stability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Lactate Ringer's Solution

Drug

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

Primary outcomes

  1. 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

    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.

Secondary outcomes

  1. 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

  2. Intraoperative use of vasoactive drugs.

    Time frame: Intraoperative period, at an average of 2 hours

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

    Time frame: The first postoperative day, at 24 hours after surgery

    SOFA score grades organ dysfunction from 0 (normal) to 4 (most abnormal) for six organ systems . The total score is the sum of all six sub-scores, ranging from 0 to 24 . The higher score means the worse organ function.

  4. Length of hospital stay.

    Time frame: The duration of the patient's hospitalization after the initial surgery, at an average of 5 days.

  5. 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)

  6. In-hospital all-cause mortality

    Time frame: During the postoperative period prior to discharge (at an average of 5 days)

  7. All-cause mortality within 30 days postoperatively

    Time frame: 30 days after surgery

  8. Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period

    Time frame: 30 days after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Lu

CONTACT

[email protected]

86-13891975018

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: CHAIN-T

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 9, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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