NCT04393493

The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.

The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide. A Randomized Controled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Hospital Civil de Guadalajara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.

Detailed description

In a patient with type 1 cardiorenal syndrome, we tried to compare two Furosemide strategies: both with a morning bolus, and randomized in two groups: Group A: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution * Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution * Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution * Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution Group B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally: * Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. * Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs. ution + Chlortalidone 50mg VO every 24 hours + Spironolactone 25mg VO every 24 hrs. With the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations.

Conditions

• Cardiorenal Syndrome

Interventions

Type	Name	Description
DRUG	Furosemide intravenous solution	Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.
DRUG	Chlortalidone	One 50 mg pill administrated every 24 hours in group B
DRUG	Spironolactone	One 50 mg pill administrated every 24 hours in group B

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2020-05-19
• Last updated: 2020-09-14
• Results posted: 2020-09-14

Locations

2 sites across 1 country: Mexico