Once Versus Twice Daily Electrolyte Monitoring in CHF
Status: | Completed |
---|---|
Conditions: | Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/28/2017 |
Start Date: | October 2015 |
End Date: | August 2017 |
Once Versus Twice Daily Electrolyte Monitoring in CHF; a Study Monitoring Electrolytes in Congestive Heart Failure Patients Being Actively Diuresed in Hospital
Twice daily basic metabolic panel's or labs are common practice at Vanderbilt University
Medical Center. However, it is unclear how often the second BMP each day is acted on. the
investigators project aims to answer a few fundamental questions about the need for twice
daily labs in patients hospitalized with acute/subacute-decompensated congestive heart
failure who are being actively diuresed.
Medical Center. However, it is unclear how often the second BMP each day is acted on. the
investigators project aims to answer a few fundamental questions about the need for twice
daily labs in patients hospitalized with acute/subacute-decompensated congestive heart
failure who are being actively diuresed.
Background: Over 5 million Americans are currently suffering from heart failure, resulting in
over 1 million hospital admissions each year. Heart failure hospitalizations are one of the
most expensive medical problems facing Americans today]. Admissions for acute decompensate
heart failure exacerbations are managed medically through oral and intravenous (IV)
diuretics. Side effects of diuretics are well established, the most common of which is
metabolic derangements, more specifically alterations in levels of potassium . Clinical
manifestations of hypokalemia and hyperkalemia are most commonly muscle cramps and clinically
insignificant arrhythmia. The most concerning manifestations of hypo and hyperkalemia include
symptomatic arrhythmia, myalgia, and more rarely rhabdomyolysis. Active use of diuretics
requires monitoring of serum electrolytes to prevent clinically significant derangements in
potassium. The frequency of monitoring required to prevent these events has not been
established. Monitoring is thus provider dependent. At our single large academic medical
center monitoring frequency ranges from 1-2 times daily on average. In this trial we will
determine whether twice-daily electrolyte labs result in less frequent clinically hypo or
hyperkalemia. We will also investigate a multitude of other outcomes including potential cost
savings by reduced laboratory test ordering.
Intervention: Randomization of study population to ONCE daily scheduled BMP or TWICE daily
scheduled BMP.
Risk: Risks to both arms of the study are in clinical equipoise and include: Hypokalemia,
hyperkalemia, arrhythmia (secondary to hypokalemia or hyperkalemia), delayed identification
of rising creatinine (acute kidney injury).
Project goals: Twice daily basic metabolic panel's or labs are common practice at Vanderbilt
University Medical Center. However, it is unclear how often the second BMP each day is acted
on. Our project aims to answer a few fundamental questions about the need for twice daily
labs in patients hospitalized with acute/subacute-decompensated congestive heart failure who
are being actively diuresed.
Descriptive:
Age Race Sex JVP on admission JVP on discharge Congestion on CXR Left ventricular ejection
fraction Diabetes (Type I, or Type II [defined as HgA1C >6.5%]) Type of cardiomyopathy- ICM
vs NON Ace-I or ARB Beta blocker Aldosterone antagonist HF hospitalization within past 12
months Na K (all recorded during stay) Cl BUN Cr (all recorded during stay and most recent
prior to hospitalization) Total dose of loop diuretics received during admission Total dose
of thiazide diuretics received Total dose of mineralocorticoid antagonist received
Outcomes:
Primary: Proportion of labs spent in ideal potassium range (defined at 3.5-5.0 mmol).
Secondary: Clinically relevant hypokalemia or hyperkalemia; defined as new muscle weakness,
rhabdomyolysis, paralysis, ECG changes or conduction. Amount of potassium given, number of
times per day potassium was given and average potassium value during stay. Time free from
readmission, length of stay, change in weight (as surrogate for amount of diuresis), Input
and output, mortality at 1mo and 3mo, cost savings during admission.
over 1 million hospital admissions each year. Heart failure hospitalizations are one of the
most expensive medical problems facing Americans today]. Admissions for acute decompensate
heart failure exacerbations are managed medically through oral and intravenous (IV)
diuretics. Side effects of diuretics are well established, the most common of which is
metabolic derangements, more specifically alterations in levels of potassium . Clinical
manifestations of hypokalemia and hyperkalemia are most commonly muscle cramps and clinically
insignificant arrhythmia. The most concerning manifestations of hypo and hyperkalemia include
symptomatic arrhythmia, myalgia, and more rarely rhabdomyolysis. Active use of diuretics
requires monitoring of serum electrolytes to prevent clinically significant derangements in
potassium. The frequency of monitoring required to prevent these events has not been
established. Monitoring is thus provider dependent. At our single large academic medical
center monitoring frequency ranges from 1-2 times daily on average. In this trial we will
determine whether twice-daily electrolyte labs result in less frequent clinically hypo or
hyperkalemia. We will also investigate a multitude of other outcomes including potential cost
savings by reduced laboratory test ordering.
Intervention: Randomization of study population to ONCE daily scheduled BMP or TWICE daily
scheduled BMP.
Risk: Risks to both arms of the study are in clinical equipoise and include: Hypokalemia,
hyperkalemia, arrhythmia (secondary to hypokalemia or hyperkalemia), delayed identification
of rising creatinine (acute kidney injury).
Project goals: Twice daily basic metabolic panel's or labs are common practice at Vanderbilt
University Medical Center. However, it is unclear how often the second BMP each day is acted
on. Our project aims to answer a few fundamental questions about the need for twice daily
labs in patients hospitalized with acute/subacute-decompensated congestive heart failure who
are being actively diuresed.
Descriptive:
Age Race Sex JVP on admission JVP on discharge Congestion on CXR Left ventricular ejection
fraction Diabetes (Type I, or Type II [defined as HgA1C >6.5%]) Type of cardiomyopathy- ICM
vs NON Ace-I or ARB Beta blocker Aldosterone antagonist HF hospitalization within past 12
months Na K (all recorded during stay) Cl BUN Cr (all recorded during stay and most recent
prior to hospitalization) Total dose of loop diuretics received during admission Total dose
of thiazide diuretics received Total dose of mineralocorticoid antagonist received
Outcomes:
Primary: Proportion of labs spent in ideal potassium range (defined at 3.5-5.0 mmol).
Secondary: Clinically relevant hypokalemia or hyperkalemia; defined as new muscle weakness,
rhabdomyolysis, paralysis, ECG changes or conduction. Amount of potassium given, number of
times per day potassium was given and average potassium value during stay. Time free from
readmission, length of stay, change in weight (as surrogate for amount of diuresis), Input
and output, mortality at 1mo and 3mo, cost savings during admission.
Inclusion Criteria:
- Acute decompensated Heart failure (ADHF)
- actively being diuresed (home dose or greater of diuretics)
- presentation within 24 hr of enrollment
- having a history of chronic HF.
Exclusion criteria:
- First time heart failure diagnosis
- systolic blood pressure < 90mmHg
- patients requiring inotropes (other than digoxin) or milrinone
- estimated glomerular filtration rate <10.
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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