Cardiorenal Syndrome Clinical Trial
Official title:
Comparison of Dobutamine Versus Milrinone for Renal Recovery in Patients With Cardiorenal Syndrome-A Prospective Cohort Study in Patients With Acute Decompensated Heart Failure
Heart failure is recognized as one of the most common indications for hospitalization amongst adults aged >65 years in United States with estimated Medicare cost to be 17 billion or more. Chronic heart failure is one of the most life threatening cardiovascular disorder thought to affect nearly six million US population with 600,000 new cases every year. The heart is responsible for perfusion to all vital organs including kidneys and dysfunction in either affects both the vital organs. When dysfunction of heart leads to dysfunction of kidneys or vice versa it is referred to as cardio renal syndrome (CRS). The underlying pathophysiology for CRS has been poorly understood and considered multifactorial. Worsening renal function defined as increase in serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is associated with greater length of hospital stay, hospital readmission and death. A number of interventions have been used including giving diuretics which helps in decongestion and helps the heart pump blood more effectively. Sometimes these therapies are not effective and may even lead to worsening of renal function. In such cases , inotrope agents which increase the contractility of the heart have been used to help pump more blood to vital organs. There have been very few trials assessing the efficacy of these agents for improving kidney function .The investigators aim to assess the renal recovery with two such agents - dobutamine and milrinone in patients with cardiorenal syndrome who are coming with acute decompensated heart failure
Heart failure is recognized as one of the most common indications for hospitalization amongst
adults aged >65 years in United States with estimated Medicare cost to be 17billion or more.
Chronic heart failure is one of the most life threatening cardiovascular disorder thought to
affect nearly six million US population with annual death rate being 600,000. Cardiorenal
syndrome although not completely understood in its full context - is a term coined for
disorder of the heart and kidneys whereby acute or chronic dysfunction of one precipitates
acute or chronic dysfunction of the other. Concomitant kidney failure amongst patients with
acute decompensated heart failure is commonly observed . Direct and indirect effects of heart
failure other than hemodynamic insult have been identified as primers for acute kidney injury
and dysfunction. Patients with preexisting underlying renal disease are more likely to
develop worsening renal failure in the setting of ADHF with venous congestion being the most
important hemodynamic factor driving it. Worsening renal function defined as increase in
serum creatinine of >0.3mg/dl from baseline occurs in 20-30% of patients with ADHF and is
associated with greater length of hospital stay, hospital readmission and death. The
treatment of ADHF which includes the step up intravenous diuretic therapy in addition to
optimizing baseline medicines is limited frequently by diuretic resistance and worsening
creatinine level precluding use of Angiotensin converting enzyme inhibitors (ACEi),
Angiotensin Receptor Blocking Agents (ARBs), and Spironolactone. Ultrafiltration/Aquapheresis
still remains an option for treating non-responders to medical therapy. Inotropes have been
known to produce a beneficial hemodynamic effect on heart and lead to better titration to
oral regimen. Short term continous intravenous infusion of inotropic agents in patients with
documented severe systolic dysfunction who present with significantly depressed cardiac
output to maintain end organ perfusion has been shown to be beneficial as per the ACC/AHA
guidelines 2013 for management of heart failure. The use of intravenous inotropes remains
still a controversial topic in terms of its short lived and long term efficacy on renal
recovery in acute decompensated heart failure. In view of the large proportion of patients
admitted with acute decompensated heart failure and no real world studies comparing different
inotropes to improve kidney function, the investigators aim to compare the efficacy of
dobutamine and milrinone in improving kidney function and also their effect on length of
stay, symptomatic improvement and medication optimisation
1. The primary objective of the study is to objectively measure the response of dobutamine
vs milrinone for renal recovery in patients with cardiorenal syndrome (>0.3mg/dl
increase in creatinine from baseline) admitted for acute decompensated heart failure.
These objective measures include change in serum creatinine, change in weight.
2. The secondary objectives are to measure the length of hospitalization, readmission rates
and unscheduled visits to the clinic or ER during 60 day follow up period. The
investigators will also measure changes in symptoms which will be assessed using global
and dyspnea visual analog scale every 24 hours until the patient is discharged .
3. The secondary objectives also include to measure diuretic dose, medicine optimization
including initiation of beta blocker / ace inhibitors before discharge, at 30 days and
60 days interval
4. The investigators will subdivide the patients into ischemic versus non ischemic at the
end of trial to see the response in both these categories of patients
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