Transcatheter Aortic Valve ReplacementCHAIN-TNCT07329660
Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients
A study testing Hydroxyethyl starch 130/0.4 and Lactate Ringer's Solution in people with Transcatheter Aortic Valve Replacement and Hemodynamic Stability, run by Air Force Military Medical University, China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement, Hemodynamic Stability, Anesthesia Induction
- What is being tested?
- Hydroxyethyl starch 130/0.4 and Lactate Ringer's Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- Patients scheduled to undergo elective TAVR under general anesthesia;
Who cannot join
- 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 ;
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- Patients with preoperative intracranial hypertension requiring dehydration therapy;
- Expected postoperative hospital stay < 24 hours;
- Patients scheduled for multiple surgeries during this hospitalization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
- Being tested
- Hydroxyethyl starch 130/0.4, Lactate Ringer's Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxyethyl starch 130/0.4Drug
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 SolutionDrug
5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Colloid | Experimental | 5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection. Receives: Drug: Hydroxyethyl starch 130/0.4 |
| Crystalloid | Active comparator | 5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. Receives: Drug: Lactate Ringer's Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 15 minutes after induction
Intraoperative use of vasoactive drugs.
Measured: Intraoperative period, at an average of 2 hours
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.
Measured: The first postoperative day, at 24 hours after surgery
Length of hospital stay.
Measured: 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
Measured: During the postoperative period prior to discharge (at an average of 5 days)
In-hospital all-cause mortality
Measured: During the postoperative period prior to discharge (at an average of 5 days)
All-cause mortality within 30 days postoperatively
Measured: 30 days after surgery
Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start16 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhihong LU, Air Force Military Medical University, China
- Investigators
- Hailong Dong, Study chair, Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329660
- Sponsor's protocol ID
- XJH-A-20250824
- Acronym
- CHAIN-T
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tuo X, Wang F, Chen Y, Chen M, Lu Z. Crystalloid vs colloid for Hemodynamics during Anesthesia INduction in TAVR patients (CHAIN-T): study protocol for a randomized controlled trial. Trials. 2026 Jul 24;27(1):616. doi: 10.1186/s13063-026-09906-x.
PubMed 42902397
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients
- ClinicalTrials.gov ID
- NCT07329660
- Acronym / sponsor ID
- CHAIN-T / XJH-A-20250824
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colloid | Experimental | Drug: Hydroxyethyl starch 130/0.45 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection. |
| Crystalloid | Active comparator | Drug: Lactate Ringer's Solution5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years;
- Patients scheduled to undergo elective TAVR under general anesthesia;
Key exclusion criteria (9 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxyethyl starch 130/0.45 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction. | Drug | Colloid |
| Lactate Ringer's Solution5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction. | Drug | Crystalloid |
Primary outcome
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.
8 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.
Time frame: 15 minutes after induction
Intraoperative use of vasoactive drugs.
Time frame: Intraoperative period, at an average of 2 hours
Sequential Organ Failure Assessment(SOFA )score on the first postoperative day
Time frame: The first postoperative day, at 24 hours after surgery
Length of hospital stay.
Time frame: 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
Time frame: During the postoperative period prior to discharge (at an average of 5 days)
In-hospital all-cause mortality
Time frame: During the postoperative period prior to discharge (at an average of 5 days)
All-cause mortality within 30 days postoperatively
Time frame: 30 days after surgery
Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Derived from this study: PubMed 42902397Tuo X, Wang F, Chen Y, Chen M, Lu Z. Crystalloid vs colloid for Hemodynamics during Anesthesia INduction in TAVR patients (CHAIN-T): study protocol for a randomized controlled trial. Trials. 2026 Jul 24;27(1):616. doi: 10.1186/s13063-026-09906-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hailong Dong study chair
Air Force Medical University
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxyethyl starch 130/0.4 and Lactate Ringer's Solution in people with Transcatheter Aortic Valve Replacement and Hemodynamic Stability, run by Air Force Military Medical University, China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Lu (86-13891975018, deerlu23@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07329660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.