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

The Impact of Different Preload Strategies on 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).

Study Overview

• Status: Not yet recruiting
• Conditions: Transcatheter Aortic Valve Replacement; Anesthesia Induction; Hemodynamic Stability
• Intervention / Treatment: Drug: Hydroxyethyl starch 130/0.4; Drug: Lactate Ringer's Solution

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhihong Lu; Phone Number: 86-13891975018; Email: deerlu23@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colloid; 5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection.	Drug: 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.
Active Comparator: Crystalloid; 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.	Drug: Lactate Ringer's Solution; 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Sequential Organ Failure Assessment(SOFA )score on the first postoperative day	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.	The first postoperative day, at 24 hours after surgery

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Study Chair: Hailong Dong, Air Force Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 16, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dietary Carbohydrates; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Polysaccharides; Starch; Glucans; Hydroxyethyl Starch Derivatives; Ringer's Lactate
• Other Study ID Numbers: XJH-A-20250824

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No