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临床试验/NCT02937961
NCT02937961Unknown不适用

Early Versus Late Sustained Low Efficiency Dialysis in Critically Ill Cirrhotics With Septic Shock and Acute Kidney Injury -A Pilot Randomized Controlled Trial

Institute of Liver and Biliary Sciences, India2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
150
试验地点
2
主要终点
Transplant free survival in both groups

研究概览

简要总结

Consecutive patients with cirrhosis and septic shock with AKI who give written informed consent will be included in this prospective trial. At baseline NT-Pro BNP, urine N-GAL will be done for all patients. A baseline serum blood sample (10 ml) and urine sample will be stored. Septic shock will be defined by the presence of two or more diagnostic criteria for the systemic inflammatory response syndrome, proven or suspected infection with hypotension non-responsive to adequate fluid resuscitation assessed by no evidence of stroke volume variation on flow track and need of a vasopressor to achieve a target mean arterial pressure (MAP) of ≥ 65 mm Hg. A record of CVP, IVC diameter and B-lines on ultrasound lung would also be done. Patients with age less than 18 years, severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, COPD) pregnancy, chronic kidney disease on hemodialysis, patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group, patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit, extremely moribund patients with an expected life expectancy of less than 24 hours, failure to give informed consent from family members.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Cirrhosis with septic shock associated AKI (Acute Kidney Injury) stage 3 AKIN/KDIGO stage 2.

排除标准

  • Patients with age less than 18 years
  • Severe known cardiopulmonary disease (structural or valvular heart disease, coronary artery disease, Coronary Obstructive Pulmonary Disease)
  • Pregnancy
  • Chronic kidney disease on hemodialysis
  • Patients with Hepatorenal Syndrome, post renal obstructive AKI, AKI due to suspected based on history,urinalysis and past clinical records-glomerulonephritis, interstitial nephritis or vasculitis
  • Patients already meeting emergency criteria for immediate hemodialysis at the time of randomization as specified in the late group (serum potassium>6 meq/lt, metabolic acidosis ph<7.12, acute pulmonary edema, severe volume overload with hypoxemia non-responsive to diuretic treatment)
  • Patients transferred from other hospitals who have already been on hemodialysis before their arrival in the intensive care unit
  • Extremely moribund patients with an expected life expectancy of less than 24 hours
  • Failure to give informed consent from family members.
  • Hemodynamic instability requiring very high dose of vasopressors

研究组 & 干预措施

Early SLED

Experimental

干预措施: Early SLED (Biological)

Late SLED

Active Comparator

干预措施: Late SLED (Biological)

结局指标

主要结局

Transplant free survival in both groups

时间窗: 28 days

次要结局

  • Achievement of target ultrafiltration goals in both groups(48 hours)
  • Recovery in renal functions in both groups(14 days)
  • Duration of Intensive Care Unit stay in both groups(28 days)
  • Improvement in Sequential Organ Failure Assessment ( by 2 points) scores in both groups(28 days)
  • Death related with renal failure in both groups(7 day)
  • Mortality due to renal failure related in both groups.(7 day)
  • Hemodynamic stability in both groups(48 hours)
  • Improvement in SOFA, Model for End stage Liver Disease ( by 2 points) scores(28 days)
  • Incidence of intradialytic hypotension in both groups(48 hours)
  • Duration of mechanical ventilation in both groups(28 days)
  • Improvement in Acute Physiology and Chronic Health Evaluation ( by 2 points) scores(28 days)
  • Dialysis efficiency as measured by Urea Reduction ratio in both groups(2 days)
  • Improvement in lactic acidosis and lactate clearance at 6 initiation of dialysis in both groups(6 hours)
  • Improvement in lactic acidosis and lactate clearance at 24 hours after initiation of dialysis in both groups(24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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