- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03318055
Prevalence of Hyperglycemia and Anaemia in Elective Surgical Patients (EPIC-1)
Evaluating Perioperative Interventions to Improve Patient Outcomes (EPIC-1) Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Globally, one third of patients presenting for surgery will be anaemic, according to the WHO criteria. Preoperative anaemia is considered an independent risk factor for poorer patient outcomes, with increases in morbidity and mortality as well as prolonged length of hospital stay. However, the importance of this finding in the preoperative period is often overlooked and not corrected prior to surgery. The leading cause of preoperative anaemia is iron deficiency. Iron deficiency anaemia is common in developing countries and results mostly from nutritional deficiency. Poorly controlled Diabetes Mellitus (DM) is known to have an adverse effect on perioperative clinical outcomes, with an extended length of hospital stay and increased morbidity and mortality. Preoperative identification of patients with DM, provides a potential opportunity to reduce the risk of adverse surgical outcomes. Early identification of such patients could facilitate timely intervention and arrangement of appropriate perioperative and long-term follow-up. Studies have demonstrated that an elevated HbA1c (indicative of poor glycaemic control in the months preceding surgery) correlates with increased perioperative risk in known diabetics. On the day of surgery, before induction of anaesthesia, all patients will have a finger prick blood glucose level done by point of care glucometry, if there is no documented fasting blood glucose value in their ward file. In patients of unknown diabetic status, should the preoperative value be >7 mmol/l, blood will be drawn when IV access is established, for HbA1C measurement. In known diabetics, a sample will be taken for HbA1C, regardless of the preoperative fasting blood glucose level, unless there is an HbA1C measurement in the previous 3 months. However, should the patient management have been modified based on the HbA1C result, a repeat HbA1C measurement would be performed
All patients will be assessed as part of the routine preoperative evaluation. Informed consent will be obtained by the anaesthetist from eligible patients who agree to participate in the study. On the day of surgery, prior to induction of anaesthesia the patients will receive a finger prick Hemoglobin (Hb) if they have not had a Hb result documented within the last 3 months. If the results meet the WHO criteria for anemia, a blood specimen will be collected when inserting the IV line. The blood specimen will be sent for Haemoglobin, mean cell volume, ferritin and transferrin saturation (TSAT) testing. All patients diagnosed with anemia will receive a patient information leaflet. They will also be referred to their local clinics or general practitioner for further evaluation and appropriate management.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Western Cape
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Cape Town, Western Cape, Sudáfrica, 7599
- Mitchells Plain Hospital
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Cape Town, Western Cape, Sudáfrica, 7599
- Somerset Hospital
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Cape Town, Western Cape, Sudáfrica, 7599
- Victoria Hospital
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Cape Town, Western Cape, Sudáfrica, 7599
- Groote Schuur Hospital
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George, Western Cape, Sudáfrica, 7599
- George Hospital
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Paarl, Western Cape, Sudáfrica, 7599
- Paarl 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:
- Adult, non-cardiac, non-obstetric, elective surgical patients
Exclusion Criteria:
- Obstetric, emergency and cardiac patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Single group study
The study population will include patients presenting for elective surgery, who fulfil the inclusion criteria of all surgical disciplines undergoing elective surgery period during the period of the study. Inclusion Criteria: > 18 years of age Non-cardiac patients Non-obstetric patients Patients receiving general, neuraxial, regional or local/topical anaesthesia for elective surgical intervention |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prevalence of diagnosis of diabetes and anaemia
Periodo de tiempo: Day of surgery
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Proportion of patients with diagnosis of diabetes and anaemia
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Day of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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HbA1C level
Periodo de tiempo: Day of surgery
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Assessment of diabetic control
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Day of surgery
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Transferrin saturation
Periodo de tiempo: Day of surgery
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Diagnosis of iron deficiency anaemia
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Day of surgery
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Serum ferritin
Periodo de tiempo: Day of surgery
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Diagnosis of iron deficiency anaemia
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Day of surgery
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Netjhardt Marcin, MBChB, FCA, University of Cape Town
- Investigador principal: Francois Roodt, MBChB, FCA, University of Cape Town
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- EPIC1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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