Study Stopped
We randomized 18 patients, but was impossible to measure adrenomedullin in Brazil. However, we analysed some interesting clinical and laboratorial results.
The Role of Adrenomedullin on the Outcome of Severe Heart Failure: a Clinical Randomized Study
1 other identifier
interventional
N/A
1 country
1
Brief Summary
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2010
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 28, 2010
CompletedFirst Posted
Study publicly available on registry
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 4, 2016
November 1, 2016
8 months
June 28, 2010
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration.
90 days after randomization (plus or minus 3 days).
Levels of Adrenomedullin plasma in different treatments- clinical,ultrafiltration and isovolumetric hemofiltration
The adrenomedullin level will be compared in three different treatments: clinical treatment, ultrafiltration treatment and isovolumetric hemofiltration. The patients will be followed until discharge.
at discharge
Secondary Outcomes (10)
The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to clinical outcome.
90 days after randomization (plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
at discharge
The Adrenomedullin plasma levels in three different treatment approaches will be related to oxydative stress
90 days after randomization(plus or minus 3)
The Adrenomedullin plasma levels in three different treatment approaches will be related to angiotensin II plasma level
at discharge
- +5 more secondary outcomes
Study Arms (3)
clinical treatment
OTHERPatients with previous diagnosis of decompensated III and IV Heart Failure will be included. The clinical treatment will be optimized. Clinical assessment, Adrenomedullin, Angiotensin II, Brain Natriuretic Peptide, oxydative stress, sympathetic nervous system activity will be evaluated at the beginning, at discharge and 90 days after randomization(plus or minus3).
ultrafiltration
EXPERIMENTALultrafiltration will be done on decompensated patients III and IV acute heart failure on Intensive Care Unit. This patients will have biochemical analysis, adrenomedullin, angiotensin II,Brain Natriuretic Peptide, oxydative stress measurements,sympathetic nervous system activity evaluated and clinical outcome analyzed at the beginning,at discharge and 90 days after randomization(plus or minus 3). Diuretic will be withdrawn during ultrafiltration.
isovolumetric hemofiltration
EXPERIMENTALPatients randomized to this group will have isovolumetric hemofiltration on Intensive Care Unit. They will have biochemical analysis, Adrenomedullin plasmatic level, Brain Natriuretic Peptide Level, Angiotensin II level, Oxydative stress measurement,sympathetic nervous system, and clinical outcome evaluated at the study beginning,at discharge and 90 days after randomization(plus or minus 3).
Interventions
The clinical treatment will be optimized to gold standard international heart failure treatment
The ultrafiltration procedure will be done on Intensive Care Unit with automatic machine and HF 1400 filter. The fluid will be removed until a increased of 10% in hematocrit or clinical improvement.
The isovolumetric hemofiltration will be done in Intensive Care Unit for 8 hours, and will be permitted the diuretic use.The dose will be 35 ml/kg/hour and will e used automatic machine and MF1400 filter.Diuretic use will be maintained.
Eligibility Criteria
You may qualify if:
- more than two item:
- more than eighteen years of age
- orthopnea
- Chest Rx with cardiomegaly and pulmonary infiltration
- edema
- diuretic resistance
You may not qualify if:
- insulin dependent diabetes
- hepatic cirrhosis
- vascular access problems
- creatinine more than 2,5 mg/dl before acute heart failure
- systemic infection
- aortic stenosis and heart transplantation
- radiologic contrast up to 72 hours prior randomization
- advanced neoplasia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Cardiologia
Porto Alegre, Rio Grande do Sul, 94801970, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 28, 2010
First Posted
July 1, 2010
Study Start
April 1, 2010
Primary Completion
December 1, 2010
Study Completion
December 1, 2012
Last Updated
November 4, 2016
Record last verified: 2016-11