- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02356484
Surgical Stress Markers for Postoperative Complications: a Prospective Study
Predictive Value of Surgical Stress Markers for Postoperative Complications: a Prospective Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age >18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.
Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Vaud
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Lausanne, Vaud, Suiza
- University of Lausanne Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients over 18 years old
- Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery
- Operation time more than 2 hours
- Operation including an organ resection for benign or malignant disease
Exclusion Criteria:
- Immunosuppressive therapy
- Cognitive impairment or language comprehension problems
- Absence of the consent form prior to first blood sample
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Major abdominal surgery cohort
In this surgical cohort, 4 inflammatory markers were measured: albumin, procalcitonin, CRP and lactate levels
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications
Periodo de tiempo: Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
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Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery)
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Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Martin Hübner, MD, University of Lausanne Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 471/14
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