Dobutamaine Versus Milrinone in Cardiorenal Syndrome

Withdrawn before enrolling · Phase 2

Conditions studied: Cardiorenal Syndrome

In brief

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

Key facts

Study ID

NCT02644057

Run by

Maimonides Medical Center

People needed

0

Starts

2016-03-01

Expected to finish

2016-09-01

Last updated by the study team

2018-08-10

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Admitted to the hospital with a primary diagnosis of Decompensated Heart Failure
• Onset of cardio-renal syndrome (increasing creatinine>0.3mg/dl) after or before hospitalization. After hospitalization within 7 days of from the time of admission after receiving intravenous diuretics and heart failure medication optimization. Before hospitalization in the setting of escalating doses of outpatient loop diuretics and heart failure medication optimization
• Persistent volume overload- For patients with a pulmonary artery catheter, peristent volume overload will include :
• Pulmonary capillary wedge pressure >22mm Hg and one of the following clinical signs :2+ peripheral edema and/or pulmonary edema or pleural effusion on chest Xray. For patients without a pulmonary artery catheter- persistent volume overload will include atleast 2 of the following: 2+ peripheral edema , jugular venous pressure >10 mm Hg and pulmonary edema or pleural effusion on chest Xray
• BNP>400
• Cr-1.2-3.0

You may not qualify if…

• Intravascular volume depletion
• Acute coronary syndrome within 4 weeks
• Indication for hemodialysis
• Systolic Blood pressure <90mm Hg or MAP<60mm Hg at the time of enrollment
• Alternate explanation for worsening renal function , such as obstructive nephropathy , contrast induced nephropathy , ATN
• Clinical instability likely to require the addition of intravenous vasoactive drugs including vasodilators and/or inotropic drugs
• The use of iodinated radio-contrast material in the past 72 hours or anticipated use of intravenous contrast during the current hospitalization
• Underlying rhythm disorder

Where it is running

• Maimonides Medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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