ROLE OF ADDITIONAL PROTEIN TO INCREASE URINE VOLUME IN ICU PATIENTS ON URINE MAKING MEDICINES.
- Conditions
- Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/09/036705
- Lead Sponsor
- HARSHA SINHA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Age > 18 years
2. Hypoalbuminemia with serum albumin <2.5 g/dl
3. Hemodynamically stable
4. Cumulative positive fluid balance measured since ICU admission >2 liters
5. Negative fluid responsiveness on inferior vena cava (IVC) assessment with ultrasound or as per mini fluid challenge if abdomen not accessible
1. Pregnant patients
2. Lack of consent from patient/ legally authorized representative
3. Head injury patients and patients with central nervous system pathology
4. Patients with cirrhosis, nephrotic syndrome, CKD on dialysis, AKI requiring dialysis
5. Received albumin or furosemide in the last 12 hours
6. Hypernatremia (serum sodium >150 mEq/L) and/or hypokalemia (serum potassium <2.5 mEq/L)
7. Right ventricular failure
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify if there is more effective diuresis, measured as change in cumulative fluid balance between baseline and at end of intervention of at least 750 ml, when furosemide is co-administered with albumin compared to furosemide alone. <br/ ><br>Timepoint: 72 hours
- Secondary Outcome Measures
Name Time Method Comparison between 2 groups: <br/ ><br>1. Difference in urine output. <br/ ><br>2. Quantification of free water clearance using urine electrolytes. <br/ ><br>3. Change in Serum albumin, sodium,potassium,creatinine <br/ ><br>4. Incidence of Acute kidney injury <br/ ><br>5. Cumulative furosemide dose administered . <br/ ><br>6. Incidence of hypotension. <br/ ><br>7. Incidence of hypernatremia <br/ ><br>8. 28 day mortality <br/ ><br>9. Length of ICU stay. <br/ ><br>10. Change in PaO2/FiO2 ratio during intervention period. <br/ ><br>11. Ventilator free days till 28 days /ICU discharge <br/ ><br>Timepoint: 72 hours for secondary outcomes 1 to 7th. <br/ ><br> <br/ ><br>28 days for secondary outcomes 8 to 11th.