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临床试验/CTRI/2025/02/081204
CTRI/2025/02/081204尚未招募不适用

Early Outcomes In Patients Newly Initiated On Hemodialysis

Hardik Sheth1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To understand the early outcomes in patients newly initiated on Hemodialysis.

研究概览

简要总结

Renal replacement therapies include hemodialysis, peritoneal dialysis and Renal transplant. Hemodialysis is an extracorporeal process of removing waste products like free water, creatinine and urea, thus maintaining homeostasis in a state of kidney failure.[1]

There are 3 types of dialysis – Slow (or sustained) low efficiency daily dialysis, Continuous renal replacement therapy, Intermittent hemodialysis. The basic principle behind dialysis is diffusion of solutes through a semipermeable membrane. This is achieved by countercurrent flow which helps keep dialysate and blood flowing in opposite direction, thus achieving a gradient across the membrane while attaining maximum efficiency of dialysis. Free water removal is achieved by ultrafiltration, a process of altering the hydrostatic pressure of the dialysate compartment, causing free water and some dissolved solutes to move across the membrane along a created pressure gradient. Dialysate, the main dialysis solution has a sodium and chloride content similar to that of plasma while having slightly higher levels of bicarbonate and glucose to compensate for metabolic acidosis and hypoglycemia respectively. The electrolyte content of the dialysate can be adjusted to compensate for dyselectrolytemia. [2]

Hemodialysis may result in complications such as:

·      Fluid shifts – occurs when fluid is removed too rapidly or large amount of fluid is removed. This leads to common side effects like hypotension, hypertension, cramps, headache, nausea/vomiting, fatigue, chest pain, etc.  These symptoms are commonly refered to as dialysis hangover/washout.

·      First use syndrome – is a rare but severe anaphylactic reaction to the components of dialysis mainly the dialyser filaments or the chemical sterilants used to sterilize it. [3]

·      Dialysis disequilibrium syndrome – a neurological syndrome mostly associated with patients newly initiated on hemodialysis or those who have missed multiple cycles. Caused by reverse urea effect due to rapid removal of urea or intracerebral acidosis. Symptoms include headache, nausea, blurred vision, dizziness, muscle cramps, seizure, somnolence, stupor, or coma which can even lead to death in severe cases.[4]

·      Electrolyte imbalance – Mainly causing imbalance in potassium (hyperkalemia or hypokalemia) and sodium (hyponatremia or hyponatremia) levels. This greatly increases the risk of cardiovascular deaths.[5]

·      Cardiovascular complications – one of the most common complications associated with hemodialysis. Complications include arrhythmias of which diaysis associated complex ventricular arrhythmia is the most common.

There is limited data available on complications of newly initiated dialysis patients especially in Indian population. Through this study we analyse the various complications associated with initiating dialysis, outcomes of patients after initiation, and correlate the clinical profile of these patients with various laboratory investigations.

研究设计

研究类型
Observational

入排标准

年龄范围
19.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • All indoor and outdoor patients newly initiated on hemodialysis
  • Age more than 18 years
  • Willing to give consent.

排除标准

  • Patients already on hemodialysis
  • Patients with age more than years are excluded from the study.

结局指标

主要结局

To understand the early outcomes in patients newly initiated on Hemodialysis.

时间窗: One year.

次要结局

  • 1. Study the various complications associated with initiating hemodialysis.(2. To evaluate clinical profile of patient newly initiated on hemodialysis.)

研究者

发起方
Hardik Sheth
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Hardik Sheth

D Y Patil University School of Medicine

研究点 (1)

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