Clinical Trial: Dobutamaine Versus Milrinone in Cardiorenal Syndrome

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Fa

Brief Summary: 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

Detailed Summary:

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 pr
Sponsor: Maimonides Medical Center

Current Primary Outcome: Serum creatinine measured in mg/dl(milligram/decilitre) [ Time Frame: Serum Creatinine would be measured every 24 hours in mg/dl from the time of enrollment in the study and will be measured every 24 hours up to a maximum period of 14 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Length of hospitalisation [ Time Frame: Length of stay measured in days up to a maximum of 30 days ]
    Length of stay will start from the day patient is admitted up to a maximum of 30 days
  • Readmission rate [ Time Frame: Readmissions would be assessed for a period of 90 days ]
  • Global visual analog score [ Time Frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days ]
  • Dyspnea visual analog score [ Time Frame: Every 24 hours starting from the day of enrollment in the study up to a maximum period of 14 days ]
  • Urine output measured in milliliters in a 24 hour period [ Time Frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days ]
    Urine output would be strictly monitored in millilitres /24 hours starting from the day of enrollment in the study till the patient is discharged from the hospital


Original Secondary Outcome:

  • Length of hospitalisation [ Time Frame: Length of stay measured in days up to a maximum of 60 days ]
    Length of stay will start from the day patient is admitted up to a maximum of 60 days
  • Readmission rate [ Time Frame: Readmissions would be assessed for a period of 90 days ]
  • Global visual analog score [ Time Frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days ]
  • Dyspnea visual analog score [ Time Frame: Every 24 hours starting from the day of enrollment in the study up to a maximum period of 14 days ]
  • Urine output measured in milliliters in a 24 hour period [ Time Frame: Every 24 hours from the day of enrollment in the study up to a maximum period of 14 days ]
    Urine output would be strictly monitored in millilitres /24 hours starting from the day of enrollment in the study till the patient is discharged from the hospital


Information By: Maimonides Medical Center

Dates:
Date Received: October 29, 2015
Date Started: March 2016
Date Completion:
Last Updated: March 11, 2016
Last Verified: March 2016