Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:40 AM
Study NCT ID:
NCT07329660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-16', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2025-12-29', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period.', 'timeFrame': 'induction period, at an average of 15 minutes', 'description': 'The AUC below baseline MAP is calculated as:\n\n∑ (((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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '15 minutes after induction'}, {'measure': 'Intraoperative use of vasoactive drugs.', 'timeFrame': 'Intraoperative period, at an average of 2 hours'}, {'measure': 'Sequential Organ Failure Assessment(SOFA )score on the first postoperative day', 'timeFrame': 'The first postoperative day, at 24 hours after surgery', 'description': '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.'}, {'measure': 'Length of hospital stay.', 'timeFrame': "The duration of the patient's hospitalization after the initial surgery, at an average of 5 days."}, {'measure': 'Proportion of patients admitted to the intensive care unit (ICU) after surgery', 'timeFrame': 'During the postoperative period prior to discharge (at an average of 5 days)'}, {'measure': 'In-hospital all-cause mortality', 'timeFrame': 'During the postoperative period prior to discharge (at an average of 5 days)'}, {'measure': 'All-cause mortality within 30 days postoperatively', 'timeFrame': '30 days after surgery'}, {'measure': 'Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transcatheter Aortic Valve Replacement', 'Hemodynamic Stability', 'Anesthesia Induction']}, 'descriptionModule': {'briefSummary': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Patients scheduled to undergo elective TAVR under general anesthesia;\n\nExclusion Criteria:\n\n* Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy;\n* Severe cardiac dysfunction (ejection fraction\\[EF\\] \\< 35%);\n* Severe renal dysfunction (creatinine \\> 132 μg/L and/or requiring renal replacement therapy);\n* Morbid obesity (body mass index\\[BMI\\] \\> 37.5 kg/m² or \\> 32.5 kg/m² with metabolic diseases);\n* Severe hepatic dysfunction ;\n* Severe electrolyte disturbances ;\n* Patients with preoperative intracranial hypertension requiring dehydration therapy;\n* Expected postoperative hospital stay \\< 24 hours;\n* Patients scheduled for multiple surgeries during this hospitalization."}, 'identificationModule': {'nctId': 'NCT07329660', 'acronym': 'CHAIN-T', 'briefTitle': 'Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients', 'organization': {'class': 'OTHER', 'fullName': 'Air Force Military Medical University, China'}, 'officialTitle': 'The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients', 'orgStudyIdInfo': {'id': 'XJH-A-20250824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colloid', 'description': '5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection.', 'interventionNames': ['Drug: Hydroxyethyl starch 130/0.4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Crystalloid', 'description': "5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.", 'interventionNames': ["Drug: Lactate Ringer's Solution"]}], 'interventions': [{'name': 'Hydroxyethyl starch 130/0.4', 'type': 'DRUG', 'description': '5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.', 'armGroupLabels': ['Colloid']}, {'name': "Lactate Ringer's Solution", 'type': 'DRUG', 'description': "5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.", 'armGroupLabels': ['Crystalloid']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhihong Lu', 'role': 'CONTACT', 'email': 'deerlu23@163.com', 'phone': '86-13891975018'}], 'overallOfficials': [{'name': 'Hailong Dong', 'role': 'STUDY_CHAIR', 'affiliation': 'Air Force Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Air Force Military Medical University, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Zhihong LU', 'investigatorAffiliation': 'Air Force Military Medical University, China'}}}}