- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07925918
In Elderly Patients, Does Goal-directed Fluid Management Using the Carotid Corrected Flow Time (CC-FT) Index, Compared to Routine Fluid Management, Affect the Occurrence of Post-induction Hypotension?
Effect of Carotid Corrected Flow Time-Guided Volume Management on Post-Induction Hypotension in Elderly Patients
This study aims to find out whether using a simple ultrasound measurement of blood flow in the neck artery can help doctors decide how much fluid to give older patients before general anesthesia, and thereby reduce the drop in blood pressure that commonly occurs after anesthesia induction. Older adults are more likely to experience low blood pressure during anesthesia, and such drops have been linked to kidney injury, heart injury, and even death after surgery. Giving too little fluid can worsen organ blood supply, while giving too much can cause fluid overload, lung swelling, and heart strain. Currently, doctors often rely on static measures such as central venous pressure, or on invasive dynamic measures such as pulse pressure variation, but these have limited accuracy or require expensive equipment and invasive procedures. Carotid corrected flow time (FTc), measured non-invasively with ultrasound, reflects left ventricular preload and has shown promise for predicting fluid responsiveness, including in spontaneously breathing patients. However, evidence in older adults undergoing abdominal surgery remains limited to observational studies, and higher-level evidence from randomized trials is needed. We therefore plan a single-center, prospective, randomized, parallel-controlled trial in 70 patients aged 65 years or older scheduled for elective abdominal surgery under general anesthesia. Participants will be randomly assigned 1:1 to an FTc-guided prehydration group or a conventional fluid group. In the intervention group, if FTc falls below 340.7 ms, 250 mL of lactated Ringer's solution will be infused over 15 minutes, and FTc will be re-measured until it reaches at least 340.7 ms, in addition to a background infusion of 6 mL/kg/h started 30 minutes before induction. The control group will receive the same background infusion without FTc-guided adjustment. The primary outcome is the incidence of post-induction hypotension, defined as mean arterial pressure below 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction. Secondary outcomes include the area under the curve of mean arterial pressure change from baseline during induction, intraoperative use of vasoactive agents, actual pre-induction fluid volume, postoperative pulmonary complications (pulmonary edema), acute kidney injury, myocardial injury, adverse events in the post-anesthesia care unit, time to first flatus and defecation, and all-cause mortality within 30 days after surgery.
Primary Hypothesis
Compared with conventional fluid management, carotid FTc-guided prehydration before anesthesia induction will reduce the incidence of post-induction hypotension in older patients undergoing elective abdominal surgery under general anesthesia.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Zhihong LU Zhihong LU
- Número de teléfono: 86029-84775343
- Correo electrónico: deerlu23@163.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Age ≥ 65 years;
Scheduled for elective abdominal surgery under general anesthesia.
Exclusion Criteria:
ASA physical status > III;
BMI > 30 kg/m² or < 18.5 kg/m²;
History of neck surgery or neck trauma;
History of peripheral arterial disease or arteriosclerosis, carotid artery stenosis exceeding one-third of the lumen, or significant anatomical variation of the carotid artery;
NYHA functional class > III;
History of cardiomyopathy or valvular heart disease;
Non-sinus rhythm;
Concomitant hypotension due to conditions such as septic shock;
Refusal to participate in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: CC-FT Guided Fluid Management Group
atients will receive fluid management guided by the Carotid Corrected Flow Time (CC-FT) index during anesthesia induction. |
Patients will receive fluid management guided by the Carotid Corrected Flow Time (CC-FT) index during anesthesia induction. |
|
Comparador activo: Conventional Fluid Management Group
Patients will receive routine fluid management based on standard clinical parameters during anesthesia induction. |
Patients will receive routine fluid management based on standard clinical parameters during anesthesia induction. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
ncidence of post-induction hypotension
Periodo de tiempo: defined as within 15 minutes after induction
|
Incidence of MAP < 65 mmHg or a decrease of more than 20% from baseline |
defined as within 15 minutes after induction
|
Colaboradores e Investigadores
Patrocinador
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Finalización del estudio (Estimado)
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
- XJH-A-20261015
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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