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ROLE OF ADDITIONAL PROTEIN TO INCREASE URINE VOLUME IN ICU PATIENTS ON URINE MAKING MEDICINES.

Comparison of diuresis with furosemide versus furosemide with albumin during de-resuscitation phase of sepsis in hypoalbuminemic patients:a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036705
Enrollment
90
Registered
2021-09-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Intravenous administration of furosemide with twenty percent albumin: 0.3 mg per kg IV furosemide bolus plus 1mg/kg given as infusion over 24 hours

Sponsors

HARSHA SINHA
Lead Sponsor
Dr Rahul Kumar Anand
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 18 years 2. Hypoalbuminemia with serum albumin 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

Exclusion criteria

Exclusion criteria: 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 7. Right ventricular failure

Design outcomes

Primary

MeasureTime frame
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. Timepoint: 72 hours—

Secondary

MeasureTime frame
Comparison between 2 groups: 1. Difference in urine output. 2. Quantification of free water clearance using urine electrolytes. 3. Change in Serum albumin, sodium,potassium,creatinine 4. Incidence of Acute kidney injury 5. Cumulative furosemide dose administered . 6. Incidence of hypotension. 7. Incidence of hypernatremia 8. 28 day mortality 9. Length of ICU stay. 10. Change in PaO2/FiO2 ratio during intervention period. 11. Ventilator free days till 28 days /ICU discharge Timepoint: 72 hours for secondary outcomes 1 to 7th. 28 days for secondary outcomes 8 to 11th.—

Countries

India

Contacts

Public ContactHarsha Sinha

AIIMS

drrahulkanand@gmail.com9535616756

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026