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Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

NCT07329660 — Not applicable, Not yet recruiting, 116 participants, Air Force Military Medical University, China

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

RegistryNCT07329660, acronym CHAIN-T
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment116 (Estimated)
SponsorAir Force Military Medical University, China (Other)
ConditionsTranscatheter Aortic Valve Replacement, Hemodynamic Stability, Anesthesia Induction
InterventionsHydroxyethyl starch 130/0.4, Lactate Ringer's Solution (Drug)
Datesstart 2026-02-16 (estimated), primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2026-01-09, last updated 2026-02-27

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-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).

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+Arms and interventions

ArmTypeInterventionsDescription
ColloidExperimentalDrug: Hydroxyethyl starch 130/0.45 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection.
CrystalloidActive comparatorDrug: Lactate Ringer's Solution5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.
  • 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.

+Outcome measures

Primary outcomes

  • The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period. [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

  • 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]: 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.
  • 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)]
  • In-hospital all-cause mortality [During the postoperative period prior to discharge (at an average of 5 days)]
  • All-cause mortality within 30 days postoperatively [30 days after surgery]
  • Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period [30 days after surgery]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Investigators

My Notes