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
- 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
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