Exploring Diuretics Effective Management in Acute Decompensated Heart Failure, EDEMA Trial
NCT03863626 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2021-01-27
Summary
1. Evaluate efficacy and safety of continuous infusion of IV Frusemide compared to IV shots in acute decompensated heart failure ADHF
2. Evaluate superiority of time-adjusted metolazone to morning frusemide IV shots compared to irrespective administration (at random times) to overcome diuretic resistance
Conditions
- Acute Decompensated Heart Failure
- Diuretics Resistance
Interventions
- OTHER
-
Frusemide IV shots
giving frusemide by IV shots And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade comparing its administration timed 60 minutes prior to the morning Frusemide shot versus given after. (This will be in a second level of randomization)
- OTHER
-
Frusemide IV infusion
giving frusemide by continuous IV infusion And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade
Sponsors & Collaborators
-
Kasr El Aini Hospital
collaborator OTHER -
Cairo University
lead OTHER
Principal Investigators
-
Ahmed Shehata, MD · Cairo University
-
Magdy Abdelhamid, MD · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-31
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
Countries
- Egypt
Study Locations
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