RecruitingNot ApplicableNCT07417969

"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"

"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"


Sponsor

Jose J Zaragoza, MD MSc

Enrollment

56 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the effectiveness of furosemide alone versus the combination of furosemide plus albumin in critically ill adult patients with fluid overload. The trial evaluates whether co-administration of albumin enhances diuretic response compared with standard furosemide therapy. The primary outcomes include urine output at 2 hours, changes in renal perfusion markers, and biochemical parameters. Secondary outcomes include changes in mean arterial pressure, electrolyte balance, and renal resistance index. The study seeks to determine whether adding albumin provides a clinically meaningful improvement in diuresis and renal function compared with furosemide monotherapy.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Adults ≥ 18 years of age admitted to the intensive care unit (ICU) without mechanical ventilation.
  • Patients for whom diuretic therapy will be initiated for the first time during the ICU stay due to clinical signs of fluid overload, as determined by the treating physician.

Exclusion Criteria5

  • Patients or family members who refuse participation in the study.
  • Patients receiving palliative care.
  • Patients with kidney failure requiring renal replacement therapy.
  • Patients currently participating in another clinical research protocol.
  • Patients with clinical evidence of hypovolemia or dehydration.

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Interventions

DRUGFurosemide plus albumin

Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.

DRUGFurosemide (Diuretic)

Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).


Locations(1)

76000

Querétaro City, Querétaro, Mexico

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NCT07417969