Furosemide
DrugProtocol for the use of diuretics
NCT Number: NCT03892148
The main objective of the study is to determine if a diuretic adaptation protocol in the decompensation of chronic heart failure is more effective but also safer than the current non-protocolized practice.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Ch Annecy, Annecy, France
Diuretics are the main treatment for congestive decompensation of chronic heart failure. For symptomatic purposes, the goal is to decrease the volume overload. In these patients, loop diuretics are used in high doses, sometimes in combination with other classes of diuretics such as thiazides to achieve synergistic, faster and more effective action, and to combat diuretic's resistance. This use, well known to cardiologists and based on a rich pharmacology, more than 40 years old, lacks robust scientific data in real life. Current studies are mainly based on patients with renal insufficiency or limited to cardio-renal syndrome. The CARRESS-H study in 2012 is one of them. The protocol for the use of diuretics from this study was included in 2017 as a benchmark in a publication of the NEJM. It therefore seems necessary to consider the exercise of this protocol in the management of the decompensation of chronic cardiac heart failure. There is, to the investigator's knowledge, no similar study to test this protocol as a "real life" exercise.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Protocol for the use of diuretics
Protocol for the use of diuretics
Time frame: at 96 hours of admission
serum creatinine
Time frame: at 96 hours of admission
The weight will be measured in kilograms
Time frame: at 1 month
Length of time of intravenous administration of diuretics in days
Time frame: at 1 month
Acute kidney injury requiring interruption of treatment
Time frame: at month
Severe hypokalaemia means hypokalaemia that requiring interruption of treatment, dialysis or transfer in intensive care.
Time frame: At 30 days after the date of randomisation
Number of rehospitalization for heart failure or kidney failure
Time frame: At 30 days after the date of randomisation
Number of death of participants
Time frame: At 30 days after the date of randomisation
Comparison of diuretics dose of Furosemide and/or Thiazid diuretic. The dose will be measured on milligrams per day.
Time frame: At 30 days after the date of randomisation
Description and comparison of global cost between the two groups
Time frame: At 30 days after the date of randomisation
Estimated plasma volume change captured via hemoglobin-to-hematocrit ratio (Hb/Ht) using the Strauss formula
Time frame: at 96 hours after admission of patient
The weight will be measured in kilograms
Time frame: month 1
serum creatinine
Time frame: month 1
glomerular filtration rate (GFR) estimated using the CKD-EPI equation
Time frame: month 1
NT-proBNP or BNP (as available)
Time frame: month 1
plasma volume estimated via hemoglobin-to-hematocrit ratio (Hb/Ht)
University Hospital, Clermont-Ferrand
Other
Evaluation of an Optimization Protocol for Diuretics in the Decompensation of Chronic Heart Failure: Randomized Trial in Clusters With Sequential Permutation
Acronym: ProDUCT-HF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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