Edema Signs and Symptoms
Conditions
Interventions
Patients are randomized to two groups:
1. 25% albumin, 100 mL intravenous twice daily
2. Placebo, during the duration of diuresis.
Patients will be foll
Sponsors
McMaster University Medical Centre (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 17/04/2014: Our primary outcome is feasibility, including three components: 1. Adherence to protocol (administration of first dose of study treatment within 2 hours of furosemide; proportion of patients receiving all six doses of study treatment; absence of cointervention in placebo arm as documented in the medication administration record) 2. Randomization rate of eligible patients 3. Collection of study data (including blood chemistry, hemodynamic, and oxygenation data) Previous primary outcome measures: Our primary outcome is feasibility, including three components: 1. Adherence to protocol (administration of first 3 doses of study treatment, within 2 hours of furosemide, absence of cointervention in placebo arm, as documented in the medication administration record) 2. Randomization rate of eligible patients 3. Collection of study data (including blood chemistry, hemodynamic, and oxygenation data) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/04/2014: Clinical outcomes will be secondary in this pilot study: 1. Ventilator-free days and duration of mechanical ventilation 2. Episodes interrupting treatment with furosemide 3. Fluid balance, oxygenation, hemodynamic status 4. Changes in serum electrolytes and albumin at day 1, 3, 5 5. Changes in colloid osmotic pressure at day 1, 3, 5 6. ICU and hospital mortality Previous secondary outcome measures: Clinical outcomes will be secondary in this pilot study: 1. Fluid balance, oxygenation, hemodynamic status 2. Serum chemistry data and blood gas measurements 3. Colloid osmotic pressure 4. ICU and hospital mortality | — |
Countries
Canada
Outcome results
None listed