Predicting Morbidity, Mortality, Short and Long-term Survival of End-stage Kidney Disease Patients on Hemodialysis in Central Tanzania; a Two-center Prospective Patient-registry Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
Background: In the last 2 decades, Tanzania made great improvements in the renal replacement therapy infrastructure and services. However, renal replacement therapy remains a challenge in the developing world in terms of inadequate renal registries, and limited published literature.
Objectives: This study will identify predictors of mortality, identify common causes of infection and hospitalization, their incidences, prevalence, and time-to-event analysis and analyze short and long-term survival of end-stage renal disease (ESRD) patients on hemodialysis in two hemodialysis centers in Dodoma, Tanzania. Furthermore, this study will establish a registry to be called Tanzania Registry for Chronic Renal Failure (TRCRF).
Methodology: This will be a prospective-observational study (Patient registry). It will be conducted in Tanzania, a developing world country involving two hemodialysis centers, namely Benjamin Mkapa Hospital and UDOM Health center, both affiliated with the University of Dodoma. Data will be collected by accessing patients' records receiving hemodialysis due to ESRD in the two centers from September 2019 to September 2024. Patients' demographics, medical history, investigation findings, and hemodialysis adequacy will be extracted as independent outcomes. In contrast, the outcome (i.e., Death) during the follow-up will be extracted as a primary dependent outcome. Binary logistic regression will be applied to come up with statistically significant predictors of deaths. Other outcomes will be incidences, prevalence, and time-to-event analysis of common causes of infection and re-hospitalization. Kaplan-Meier survival curves will be constructed from statistically significant predictors of deaths, and patients' survival at 1, 3, and 5 years will be illustrated.
详细描述
- Background
1.1 End-stage renal disease:
End-stage renal disease is the eighteenth cause of deaths worldwide. Despite relatively stable incidences, the prevalence of End-stage renal disease on renal replacement therapy has doubled from 1990 to 2010, and the toll is expected to rise further in the coming decade raising global health concerns. These findings are in line with the reported increase in the global burden of diabetes mellitus and hypertension, the two diseases accounting for the majority of etiologies for End-stage renal disease. The number of diabetes patients worldwide is projected to be 300 million by the year 2025, from 135 million reported in 1995. By 170%, this increase is projected to be more in the developing world as compared to a 42% expected increase in the developed world. Approximately a billion people every year are diagnosed with hypertension, and nearly 7.1 million dies from its complications, including cerebrovascular disease, ischemic heart disease, and End-stage renal disease.
1.2 Renal replacement therapy:
Regardless of etiology, patients with ESRD would need renal replacement therapy (RRT) such as hemodialysis, peritoneal dialysis, or a kidney transplant. Hemodialysis and peritoneal dialysis account for initial modalities of renal replacement therapies before renal transplantation is opted. It is predicted that a decade from now, the number of patients on Renal Replacement Therapy (RRT) to be 5439 million worldwide. Of three modalities, renal transplantation is reported to be superior in terms of patients' survival and quality of life. Despite kidney transplant's superiority, hemodialysis is a widely utilized of three renal replacement therapy modalities. It is estimated that of all patients who received RRT in 2008, eighty-nine percent (89%) received hemodialysis. Despite the decrease in the population of ESRD on peritoneal dialysis in developed countries, the number had doubled in ten years by the year 2008 in developing countries.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants diagnosed with end-stage renal disease due to any etiology.
- •Participants initiated on maintenance dialysis.
- •Participants attending Benjamin Mkapa Hospital or UDOM health center.
- •Eligible participants consented to participate in the study.
排除标准
- •Patients diagnosed with acute kidney injury.
- •Patients with CKD stage other than stage
- •Patients underwent kidney transplantation.
- •Patients on dialysis other than hemodialysis.
结局指标
主要结局
Survival
时间窗: 5 Years
To analyze survival of End-stage renal disease undergoing maintenance hemodialysis at 1, 3 and 5 years, at UDOM health center and Benjamin Mkapa Hospital, using Kaplan-Meier survival curves.
mortality
时间窗: 5 Years
To identify predictors for mortality among End-stage renal disease patients undergoing maintenance hemodialysis at UDOM (University of Dodoma) health center and Benjamin Mkapa Hospital using by binary logistic regression.
次要结局
- Time-to-rehospitalization survival(5 years)
- Prevalence of rehospitalization causes(5 Years)
- Infection incidence(5 Years)
- Infection prevalence(5 Years)
- Time-to-infection survival(5 Years)
- Incidences of rehospitalization(5 Years)
研究者
Joel Dominic Swai, MD
Resident Physician-Internal Medicine Department
Benjamin Mkapa Hospital