Phase 2
N=80
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.
Cardiorenal Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04393493 ↗Enrolled (actual)
80
Serious AEs
6.3%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values — 8; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Furosemide intravenous solution (Drug); Chlortalidone (Drug); Spironolactone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Civil de Guadalajara
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Renal Function Recovery Defined as a Return to Individual Baseline Serum Creatinine Values |
8; 5 | — |
| SECONDARY Change in 24 Hour Urine Output at 96 Hours After Intervention Started From 24 Hour Urine Output One Day Before Intervention Initiation) |
125; 200 | — |
| SECONDARY Change in Serum Creatinine at Day One of Intervention From Serum Creatinine at 96 Hrs After Intervention Started |
0.02; 0.2 | — |
| SECONDARY An Elevation of at Least 0.3 mg/dl of Serum Creatinine From Day One of Intervention Compared With Serum Creatinine at 96hrs After Intervention Started |
20; 24 | — |
| SECONDARY In Hospital Mortality Defined as Number of Dead Patients From Day One of Intervention and Before Discharge |
4; 4 | — |
| SECONDARY Mortality During Follow up Defined as Number of Dead Patients After Discharge |
9; 12 | — |
| SECONDARY Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements at 96 Hours After Intervention Started |
27; 27 | — |
| SECONDARY Number of Patients With Dyspnea Improvement as Referred by the Patient or Reduction in Supplementary Oxygen Requirements Before Day 3 of Intervention |
2; 7 | — |
| SECONDARY Number of Days From the Beginning of the Intervention Until Patients Referred Dyspnea Improvement or a Reduction in Supplementary Oxygen Requirements Was Made. |
4; 4 | — |
| SECONDARY Number of Patients That Required Renal Replacement Therapy of Any Type During Intervention (4 Days). |
7; 6 | — |
Summary
In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.
Eligibility Criteria
Inclusion Criteria
- Comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge.
- Have agreed and signed informed consent
Exclusion Criteria
- Patient in chronic dialysis either peritoneal dialysis or hemodialysis.
- History of being a renal transplant recipient
- History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal replacement therapy in the last 3 months
- Pregnancy
- Impossibility to administer medication by the oral route
Data sourced from ClinicalTrials.gov (NCT04393493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.