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Trial record 100 of 242 for:    furosemide

Exploring Diuretics Effective Management in Acute Decompensated Heart Failure, EDEMA Trial (EDEMA)

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ClinicalTrials.gov Identifier: NCT03863626
Recruitment Status : Recruiting
First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborator:
Kasr El Aini Hospital
Information provided by (Responsible Party):
Ahmad Samir, Cairo University

Brief 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

Condition or disease Intervention/treatment Phase
Acute Decompensated Heart Failure Diuretics Resistance Other: Frusemide IV shots Other: Frusemide IV infusion Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial 2 equal groups for IV shots and continuous infusion of frusemide in cases of diuretic resistance, metolazone will be added for sequential blockade in the IV shots arm qualifying diuretic resistance, there will be second levle of randomization into time adjusted versus random time metolazone administration
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Diuretics Effective Management in Acute Decompensated Heart Failure, EDEMA Trial
Actual Study Start Date : January 31, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Heart Failure
Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Frusemide IV shots = group A
Frusemide as IV shots
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)


Active Comparator: Frusemide IV infusion = group B
Frusemide as continuous IV infusion
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





Primary Outcome Measures :
  1. Time to improvement of NYHA class [ Time Frame: within 5 days ]
    Time (in hours) to improvement of NYHA class

  2. Diuretic efficiency [ Time Frame: 24 hours ]
    Urine output (in ml/kg/h) per 40 mg of frusemide given as shots vs continuous infusion.


Secondary Outcome Measures :
  1. effectiveness of sequential nephron block [ Time Frame: within 5 days of adding metolazone ]
    Assessing improvement of diuresis by adding of metolazone to frusemide in ADHF.patients who had developed diuretic resistance.

  2. Evaluating superiority of timely adjusted metolazone compared to given at random in overcoming resistance to IV frusemide (only in IV shots arm) [ Time Frame: within 5 days of adding metolazone ]
    Evaluating superiority of timely adjusted metolazone given 60 minutes prior to IV frusemide compared to when given at random in overcoming diuretic resistance (only in IV shots arm)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age more than 18 years.
  • Chronic heart failure prior diagnosis, based on signs and or symptoms of heart failure, presenting with acute decompensation as judged by the physician to require hospitalization for IV diuretics

Exclusion Criteria:

  • Refusal to participate in the study.
  • Allergy to IV frusemide.
  • Severe renal impairment defined as eGFR<30ml/m.
  • Cardiogenic shock or hemodynamic instability judged by the treating physician to be unsuitable to participate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03863626


Contacts
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Contact: Ahmad Samir, MD 00201002647275 ahmad.samir@kasralainy.edu.eg
Contact: Salma Sallam 00201223359622 salma.sallam91@gmail.com

Locations
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Egypt
Faculty of Medicine, Cairo University Hospitals Recruiting
Cairo, Egypt
Contact: Salma Sallam         
Sponsors and Collaborators
Cairo University
Kasr El Aini Hospital
Investigators
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Study Chair: Ahmed Shehata, MD Cairo University
Study Director: Magdy Abdelhamid, MD Cairo University

Additional Information:
Publications:
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Responsible Party: Ahmad Samir, Lecturer of Cardiovascular Medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03863626     History of Changes
Other Study ID Numbers: N-166-2018
First Posted: March 5, 2019    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Furosemide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action