Furosemide and Albumin for Diuresis of Edema: a pilot study

Not Applicable

Completed

• Conditions: Edema; Signs and Symptoms

• Registration Number: ISRCTN70191881
• Lead Sponsor: McMaster University Medical Centre (Canada)

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-20
• Study Completion: 2015-01-01
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified