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| Name | Class |
|---|---|
| Kasr El Aini Hospital | OTHER |
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After admission for acute decompensated heart failure and ensuring eligibility to participate in the study, accepting patients will be randomized by a pre-prepared tables into 2 equal groups (A = shots, B = infusion): - Patients randomized to the Frusemide IV shots arm (group A) will be started on 80 mg frusemide daily (or at the least equal to their prior oral dose if was on >80 mg oral frusemide or equivalent doses of other loop diuretics). Dose will be allowed to be modified by judging the urine output in every 3 hours.
Patients randomized to continuous IV infusion arm (group B) will receive 84 mg Frusemide daily (40 mg bolus followed by 2 mg/ hour starting infusion rate). An extra bolus and/or modification of the infusion rate will be allowed after judging the urine output in 3 hours. The same regimen would be continued for at least 72 hours, or more than 72 hours if needed till switching to oral diuretics.
In patients who develop diuretic resistance defined as failure to achieve therapeutically desired urine output despite maximal doses of loop diuretics will be managed by adding thiazide type diuretic "Metolazone" to the regimen to achieve sequential nephron blockade. Metolazone (2.5 - 10 mg /day) addition will be allowed in both arms when deemed indicated, however, in the IV shots arm, there will be further 1:1 randomization for either giving metolazone timed 60 minutes before the morning IV frusemide shot (group A.T) or metolazone at random time irrespective of the frusemide dose timing (group A.R).
Variables that will be assessed in the patients to evaluate the prespecified end-points are:-
VI. Study outcomes
Primary outcome
Secondary outcome(s)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frusemide IV shots = group A | Active Comparator | Frusemide as IV shots |
|
| Frusemide IV infusion = group B | Active Comparator | Frusemide as continuous IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frusemide IV shots | Other | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Time to improvement of NYHA class | Time (in hours) to improvement of NYHA class | within 5 days |
| Diuretic efficiency | Urine output (in ml/kg/h) per 40 mg of frusemide given as shots vs continuous infusion. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness of sequential nephron block | Assessing improvement of diuresis by adding of metolazone to frusemide in ADHF.patients who had developed diuretic resistance. | within 5 days of adding metolazone |
| Evaluating superiority of timely adjusted metolazone compared to given at random in overcoming resistance to IV frusemide (only in IV shots arm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmad Samir, MD | Contact | 00201002647275 | ahmad.samir@kasralainy.edu.eg | |
| Salma Sallam | Contact | 00201223359622 | salma.sallam91@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Shehata, MD | Cairo University | Study Chair |
| Magdy Abdelhamid, MD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo University Hospitals | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25838436 | Background | Damman K, Testani JM. The kidney in heart failure: an update. Eur Heart J. 2015 Jun 14;36(23):1437-44. doi: 10.1093/eurheartj/ehv010. Epub 2015 Apr 2. |
| Label | URL |
|---|---|
| Hoorn EJ, Ellison DH. Diuretic Resistance. Am J Kidney Dis. 2017;69(1):136-142. doi:10.1053/j.ajkd.2016.08.027 | View source |
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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
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|
| Frusemide IV infusion | Other | 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 |
|
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) |
| within 5 days of adding metolazone |