Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-24 @ 9:12 PM
NCT ID:
NCT01154504
Brief Summary:
1. Study Hypothesis:
* The decrease of plasma adrenomedullin (ADM) concentration by ultrafiltration and isovolumetric hemofiltration in patients with acute III and IV Class New York Heart Association Functional(NYHA) heart failure is more pronounced than a standard diuretic treatment and is related with clinical improvement.
2. Outcome Measurements:
To correlate the adrenomedullin plasma levels with clinical treatment, ultrafiltration and hemofiltration related to:
* Brain natriuretic peptide (BNP) level
* angiotensin II level
* sympathetic nervous activity
* oxydative stress
* clinical outcome at the beginning, at discharge and 90 days after randomization.
Detailed Description:
Testing the hypothesis that adrenomedullin (ADM) is a important peptide in severe heart failure and that is related to clinical condition, we will study the effects of 3 different treatments (clinical usual treatment,ultrafiltration and isovolumetric hemofiltration with diuretics) to participants are followed until discharge to Adrenomedullin level and clinical outcomes,and also their relationship with angiotensin II level, brain natriuretic peptide(BNP), sympathetic nervous system and oxydative stress.
The patients will be randomized in three different treatment group and analyzed in three moments: on the randomization, at discharge and 90 days after randomization(plus or minus 3).
The clinical treatment will be optimized, the ultrafiltration will be done until clinically adequate fluid removal or until hematocrit increased 10% from basal level, and isovolumetric hemofiltration will be done for 8 hours- dose of 35 ml/kg/h in association with diuretic. All this dialytic procedures will be done with PAES membrane- filter HF1400 and automatic machine.
Study:
NCT01154504
Study Brief:
Protocol Section:
NCT01154504