Prospective Observational Study for the Validation of a Risk Score Opportunistic Infections Development in Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 577
- 试验地点
- 15
- 主要终点
- To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at six months of transplantation.
研究概览
简要总结
This study validate the usefulness of SIMPLICITY score to characterize the immune status of the kidney transplant receiver at two points along its course (the one and six months after transplantation), by determination in peripheral blood of various parameters related to cellular immunity (count subpopulations of CD3+ (cluster of differentiation 3), CD4+ (cluster of differentiation 4) and CD8+( cluster of differentiation 8)), humoral immunity (immunoglobulins count) and innate (complement).
详细描述
The monitoring of various parameters related to cellular and humoral immunity (lymphocytes, immunoglobulins and complement) through a score (SIMPLICITY) (8) would allow the identification of renal transplant recipients at high risk for post-transplant infection. Prolonged or prolonged use of CMV (Cytomegalovirus) prophylaxis may modify this risk.
The SIMPLICITY score (Seeking for Immune Status based on Peripheral Blood Lymphocytes, Immunoglobulins and Complement Activity) is a practical score based on the monitoring of readily available immunological parameters to assess the risk of infection after RT (Renal transplant). In order to perform this score, the total lymphocyte counts and peripheral blood lymphocyte subpopulations (PBLSs), serum immunoglobulin levels (IgG, IgA (Immunoglobulin A) and IgM) and serum complement levels (C3 and C4) at baseline were investigated, at one month and 6 months after transplantation.
The validation of this new score would allow to have a weapon that would lead to reduce to the maximum the pharmacological immunosuppression and to use strict prophylactic measures in these patients.
The results of the present study may provide insight into clinically and scientifically relevant aspects of infection in the recipient of an RT undergoing immunosuppressive therapy:
From the point of view of assistance, if the hypothesis of the study were confirmed, the possibility of elaborating specific strategies of prophylaxis and early treatment (antibiotic, antifungal or antiviral), adjusted to the risk of the recipient to present some infectious event during its evolution post transplantation according to the SIMPLICITY score.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Renal transplant patients whose variables can be properly monitored throughout the first year post-transplant.
- •Older than 18 years.
- •Patients who have signed the informed consent form.
排除标准
- •Infection with the human immunodeficiency virus (HIV).
- •Patient who dies during the first month after transplant.
- •Pre-transplant diagnosis of primary immunodeficiency (eg. Common variable immunodeficiency, idiopathic CD4 lymphopenia, etc)
- •Patient is participating in another clinical trial with a molecule under investigation.
结局指标
主要结局
To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at six months of transplantation.
时间窗: At 6 months from transplant
To validate the SIMPLICITY will be scored from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (\<700 mg/ dL) , C3 hypocomplementemia (\<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD3+ (\<0.500x103 MicroL at 6 months).
To validate SIMPLICITY Score to characterize the immunological situation of the RT recipient at month of transplantation).
时间窗: At 1 month from transplant
To validate the SIMPLICITY will be scored from 0 to 3, assigning one point to each of the following parameters: IgG hypogammaglobulinemia (\<700 mg/ dL) , C3 hypocomplementemia (\<83 mg/dL) and low counts in Peripheral blood of lymphocyte T CD8+ (\<0.200x103/MicroL at month 1)
次要结局
- Correlation of IgG and infectious complications(Up to 12 moths from transplant)
- Correlation of C3 and infectious complications(Up to 12 moths from transplant)
- Correlation of count lymphocyte T CD3+ in Peripheral blood and infectious complications(Up to 12 moths from transplant)
- Correlation of count lymphocyte T CD8+ in Peripheral blood and infectious complications(Up to 12 moths from transplant)
- Acute rejection with histologic confirmation by conventional criteria(Up to 12 moths from transplant)
- Mortality infectious cause(Up to 12 moths from transplant)
- Mortality otherwise.(Up to 12 moths from transplant)
- To analyze whether viremia has any impact on the occurrence of other opportunistic diseases(Up to 12 moths from transplant)
- To analyze the role of Antiviral prophylaxis and the influence in the appearance of infection or disease by CMV.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on overall survival throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on vascular disease throughout the first year of evolution.(Up to 12 moths from transplant)
- Graft loss with or without retransplantation.(Up to 12 moths from transplant)
- To analyze the influence of CMV serology in the increase of the rate of major infectious complications.(Up to 12 moths from transplant)
- To analyze the influence of Historical PRA (Panel Reactive Antibody) in the increase of the rate of major infectious complications(Up to 12 moths from transplant)
- To analyze whether CMV disease has any impact on the occurrence of other opportunistic diseases.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on graft survival throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on the incidence of acute rejection throughout the first year of evolution.(Up to 12 moths from transplant)
- CMV infection/Disease(Up to 12 moths from transplant)
- CMV viremia(Up to 12 moths from transplant)
- To analyze the influence of low lymphocyte count in the increase of the rate of major infectious complications.(Up to 12 moths from transplant)
- To analyze the role of Anticipated treatment and the influence in the appearance of infection or disease by CMV.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on diabetes throughout the first year of evolution throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on graft survival throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on the incidence of acute rejection throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on overall survival throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 1 month of transplantation on vascular disease throughout the first year of evolution.(Up to 12 moths from transplant)
- To analyze the influence of the renal transplant recipient's SIMPLICITY Score at 6 months of transplantation on diabetes throughout the first year of evolution throughout the first year of evolution.(Up to 12 moths from transplant)