Fluid Challenge and Plasma Volume, During Surgery
Colorectal Cancer · Urologic Cancer · Gynecologic Cancer · Colorectal Disorders · Benign Neoplasm
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 4
- Rango de edad
- 18 años - 85 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 65 Real
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.
Leer la descripción completa
60 patients scheduled for laparoscopic abdominal surgery, with a duration exceeding 90 minutes will be included in the study. These are randomized to three different groups (20 in each groups): The first group of patients will receive boluses of acetated Ringers 4 ml/kg body weight. The second albumin 4 ml/kg body weight and the third group albumin 20% 1 ml/kg body weight.
Hemoglobin, albumin and colloid osmotic pressure (COP) is sampled the day before surgery and in the morning directly prior to the anesthesia. Bioimpedance, urine osmolality and urine-creatinin are also measured. After induction of surgery a Cardio Q probe is inserted threw the nose into the esophagus, for circulatory measurements. Initial/baseline blood samples are taken after insufflation of carbon dioxide to the abdomen. Before every bolus of fluid and 5, (10), 15, 20, 30, 40, (50) and (60) minutes new blood samples are taken for determination of hemoglobin, albumin and COP. Artery blood gases are sampled 15 minutes after every infusion or depending on the clinical need.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Written consent to participate in the study
- For women: relevant contraceptive, menopausal or a negative pregnancy test.
- ASA category I to III
- Laparoscopic abdominal surgery, with a duration of at least 90 minutes.
- 18 to 85 years
Exclusion Criteria:
- Patients with known cardiac failure
- \<18 or \>85 years
- known allergy to albumin
- extracellular hyperhydration or hypervolemia
- kidney failure
- pregnancy or planned pregnancy
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Sin enmascaramiento
acetated Ringers
The circulatory effect of a bolus infusion with 4 ml/kg body weight of acetated Ringers will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
Drug: acetated Ringers
albumin 5%
The circulatory effect of a bolus infusion with 4 ml/kg body weight of Albumin 5% will be studied. If cardiac output increases with 10% a second bolus will be infused and further studied.
Drug: albumin 5%
albumin 20%
The circulatory effect of a bolus infusion with 1 ml/kg body weight of Albumin 20% will be studied. If cardiac output increase with 10% a second bolus will be infused and further studied.
Drug: albumin 20%
acetated Ringers DRUG
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first fluid bolus is infused. Circulatory and volume effects are studied. If cardiac output increase a second bolus is infused and studied.
albumin 5% DRUG
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
albumin 20% DRUG
After insufflation of carbon dioxide during an abdominal laparoscopic procedure, the first bolus of fluid is infused. Circulatory and volume effects are studied. If cardiac output increases a second bolus is infused and studied.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Plasma volume expansion after a fluid bolus
Plazo: 60 minutes after an intravenous fluid bolus
Plasma volume using hemoglobin as an indicator of dilution
Medidas secundarias
Fluid Balance
Plazo: 18 to 24 hours
Calculations of fluid balance
Stroke Volume
Plazo: 60 minutes after an intravenous fluid bolus
Change in stroke volume, measured with Cardio Q (oesophageal Doppler monitoring (ODM))
Arterial Blood Pressure
Plazo: 60 minutes after an intravenous fluid bolus
Mean Arterial Pressure, measured with an arterial line.
Heart Rate
Plazo: 60 minutes after an intravenous fluid bolus
Heart rate, measured with ECG and pulseoximeter.
Bioimpedance
Plazo: 18 to 24 hours
Bioimpedance measures, resistance and impedance converted to volume of body fluid compartments.
Serum Creatinin
Plazo: 18 to 24 hours
Serum Creatinin as a measure of kidney function
arterial pH
Plazo: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
arterial Base Excess
Plazo: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on arterial blood gases
arterial serum sodium
Plazo: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Sodium concentration
arterial serum chloride
Plazo: 60 minutes after an intravenous fluid bolus
Influence of a fluid bolus on Chloride concentrations
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
Vrinnevi HospitalNorrköping, Östergötland County, SwedenEstado desconocido
Equipo y fechas
- Patrocinador principal
- Joachim Zdolsek
- Inicio del estudio
- 23 oct 2023 Real
- Finalización primaria
- 10 jun 2026 Real
- Finalización del estudio
- 10 jun 2026 Real
- Primera publicación
- 13 feb 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Comparison of Albumin and Ringer's Solution for Optimization of the Plasma Volume and Hemodynamics During Laparoscopic Surgery.
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026