Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty
A Retrospective Cohort Study Investigating the Risk Factors and Long-term Outcome of Contrast Induced Nephropathy Among Vascular Patients Undergoing Lower Limb Angioplasty
Contrast induced nephropathy (CIN) is an iatrogenic renal injury following intravascular administration of radio-opaque contrast media (CM) in susceptible individuals. As the third leading cause of hospital acquired renal failure, it is associated with increased mortality, morbidity and prolonged hospital stay. Endovascular procedures have gained greater popularity in the past decade due to the advance in technology. This has also led to the increased incidence of CIN after vascular surgeries. We are conducting a retrospective cohort study in Singapore General Hospital using our perioperative database collected in the past five years.
We will be extracting relevant patient perioperative information including both clinical diagnosis and lab values. Our primary aim is to establish the incidence of CIN among vascular patients with or without pre-existing chronic renal impairment undergoing elective peripheral endovascular angioplasty. Our secondary aims are to establish the risk factors and protective factors that lead to the development of CIN in vascular patients after peripheral endovascular angioplasty. We will also be looking at the long-term outcome of patients who have developed CIN after vascular endovascular angioplasty. The results of the study will enable us to identify patients at high risk of development of CIN, thus appropriate measures can be initiated early and help with their recovery process.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
We propose a retrospective single-center cohort study conducted in Singapore general hospital. Data would be extracted in patients who have undergone peripheral endovascular angioplasty from 01/01/2015 to 01/01/2020. The data will be extracted from the eHINTs Perioperative Subject Area without any direct identifiers. The subject area has been previously curated as part of the SingHealth ODySSEy (On-prem Research Data Science and Systems Explorer) System. There will be no patient identifier collected and the data collection administration will not have any access to patient identifier. Waiver of consent is sought and no patient interaction would be required for the study.
The parameters to be extracted would include preoperative data such as patient demographics (age, gender, race, BMI), baseline comorbidities including but not limited to: hypertension, hyperlipidemia, diabetes mellitus, smoking, anemia, heart diseases (previous heart attack/history of congestive heart failure), preoperative renal function (measured by baseline Urea, creatinine, electrolytes level Na, K, Cl), preoperative long-term medication use including ACE inhibitor, ARB, beta-blocker, statin and diuretics and NSAIDS. Intraoperative data including types of anaesthesia used, operative duration, presence of intraoperative hypotension. Postoperative parameters such as mortality, length of stay in hospital and ICU, postoperative renal function measured by urea and creatinine level within 3 days and one month postoperatively.
Statistical analysis will be performed to study the risk factors for CIN in patients undergoing peripheral endovascular angioplasty.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Singapore, Singapur, 169608
- Singapore General 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:
- All patients undergoing peripheral endovascular angioplasty during the study period, at Singapore General Hospital
Exclusion Criteria:
- Patients < 21 years of age
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Patients undergoing peripheral endovascular angioplasty
Patients undergoing peripheral endovascular angioplasty.
No intervention other than what was already completed as part of routine clinical care, as this is a retrospective cohort.
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Peripheral endovascular angioplasty - using endovascular techniques to treat peripheral artery occlusive lesions.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Contrast induced nephropathy
Periodo de tiempo: 1 week post procedure
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Rise in creatinine post operatively according to KDIGO criteria
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1 week post procedure
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
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
- 2020/2659
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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