跳至主要内容
临床试验/ISRCTN70191881
ISRCTN70191881已完成未知

Hyperoncotic albumin to improve diuresis in critically ill patients: a pilot randomized controlled trial

McMaster University Medical Centre (Canada)0 个研究点目标入组 50 人开始时间: 2013年9月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
50

研究概览

简要总结

  1. 2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24919684 (added 13/06/2014) 2. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30037660 (added 12/04/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • Intensive care unit patients, medical or surgical, of at least 18 years of age who meet the following criteria:
  • 1. Hemodynamically stable for at least 24 hours
  • 1.1. Absence of persistent (>1h) hypotension (systolic blood pressure < 90 mmHg) and tachycardia (heart rate >110)
  • 1.2. Not currently on vasopressors other than low dose dopamine (less than 10 mcg/kg/min)
  • 1.3. Less than 2L crystalloid or colloid boluses or 2 units PRBCs, maintenance fluids excluded
  • 2. Hypoproteinemia
  • 2.1. Serum albumin < 30 mg/L, or total protein < 60 mg/L
  • 3. Clinical decision to diurese at least 3L net fluid balance within the next 72 hours
  • 4. For any reason, including: peripheral edema, congestive heart failure on chest x-ray, elevated CVP in the absence of right heart valvular pathology or pulmonary hypertension, elevated wedge pressure

排除标准

  • 1. Known pregnancy
  • 2. Patient or surrogate unable or unwilling to consent to blood product administration, including albumin
  • 3. History of adverse reactions or allergy to either albumin or furosemide
  • 4. Acute kidney injury (RIFLE criteria ?F? or greater - tripling of creatinine or creatinine >355 µmol/l (with a rise of >44) or average urine output below 0.3 ml/kg/hr for 24 hours) without any improvement in the past 24 hours, or otherwise expected to necessitate dialysis within 48 hours in the opinion of the treating physician
  • 5. Chronic kidney injury requiring dialysis
  • 6. Clinically documented cirrhosis
  • 7. Clinically documented nephrotic syndrome
  • 8. Serum sodium greater than 150 meq/L, or serum potassium less than 2.5 meq/L that cannot be treated prior to administration of study treatment
  • 9. Inability to measure urine output and fluid balance
  • 10. Receipt of hyperoncotic albumin within the preceding 24 hours
  • 11. Previous enrollment in this RCT, or any other research studies which may interfere with this study
  • 12. Estimated survival or ICU stay less than 72 hours.

研究者

发起方
McMaster University Medical Centre (Canada)

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