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Once Versus Twice Daily Electrolyte Monitoring in CHF

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Basic metabolic panel
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Once daily BMP

Twice daily BMP

Arm Description

Patient in this arm will receive once daily basic metabolic panel to monitor electrolytes

Patient in this arm will receive twice daily basic metabolic panel to monitor electrolytes

Outcomes

Primary Outcome Measures

Composite time spent in ideal potassium range
Patients average potassium during their stay will be compared to normal range defined at 3.5-5. 0 (mmol/l). , using general estimating equations allowing for comparisons between groups as well as interpersonally, in addition proportion of labs that are within normal values as stated about will also be compared between groups as well as proportion of labs in the ideal range in each group.

Secondary Outcome Measures

Cost associated with hospitalization
The cost of hospitalization in each of the study arms, using ICD 9 codes billed for during the stay of hospitalization and standardized costs defined by medicare
length of stay
hospital length of stay, calculated in hours from admission to discharge
readmission rate
rate of readmission for congestive heart failure

Full Information

First Posted
July 7, 2015
Last Updated
September 25, 2017
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02497742
Brief Title
Once Versus Twice Daily Electrolyte Monitoring in CHF
Official Title
Once Versus Twice Daily Electrolyte Monitoring in CHF; a Study Monitoring Electrolytes in Congestive Heart Failure Patients Being Actively Diuresed in Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Once daily BMP
Arm Type
Active Comparator
Arm Description
Patient in this arm will receive once daily basic metabolic panel to monitor electrolytes
Arm Title
Twice daily BMP
Arm Type
Active Comparator
Arm Description
Patient in this arm will receive twice daily basic metabolic panel to monitor electrolytes
Intervention Type
Other
Intervention Name(s)
Basic metabolic panel
Intervention Description
Patients blood is collected in routine fashion for basic blood chemistries
Primary Outcome Measure Information:
Title
Composite time spent in ideal potassium range
Description
Patients average potassium during their stay will be compared to normal range defined at 3.5-5. 0 (mmol/l). , using general estimating equations allowing for comparisons between groups as well as interpersonally, in addition proportion of labs that are within normal values as stated about will also be compared between groups as well as proportion of labs in the ideal range in each group.
Time Frame
entire hospital stay, an expected average of 72 hours
Secondary Outcome Measure Information:
Title
Cost associated with hospitalization
Description
The cost of hospitalization in each of the study arms, using ICD 9 codes billed for during the stay of hospitalization and standardized costs defined by medicare
Time Frame
entire hospital stay, an expected average of 72 hours
Title
length of stay
Description
hospital length of stay, calculated in hours from admission to discharge
Time Frame
entire hospital stay, an expected average of 72 hours
Title
readmission rate
Description
rate of readmission for congestive heart failure
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Brown, MD
Organizational Affiliation
Vanderbilt physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
Citation
1. American Heart Association., Heart and stroke statistical update. American Heart Association: Dallas Tx. p. v.
Results Reference
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PubMed Identifier
19564550
Citation
Ellison DH, Loffing J. Thiazide effects and adverse effects: insights from molecular genetics. Hypertension. 2009 Aug;54(2):196-202. doi: 10.1161/HYPERTENSIONAHA.109.129171. Epub 2009 Jun 29. No abstract available.
Results Reference
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PubMed Identifier
4058453
Citation
Comi G, Testa D, Cornelio F, Comola M, Canal N. Potassium depletion myopathy: a clinical and morphological study of six cases. Muscle Nerve. 1985 Jan;8(1):17-21. doi: 10.1002/mus.880080104.
Results Reference
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PubMed Identifier
9489541
Citation
Evers S, Engelien A, Karsch V, Hund M. Secondary hyperkalaemic paralysis. J Neurol Neurosurg Psychiatry. 1998 Feb;64(2):249-52. doi: 10.1136/jnnp.64.2.249.
Results Reference
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PubMed Identifier
3706349
Citation
Helfant RH. Hypokalemia and arrhythmias. Am J Med. 1986 Apr 25;80(4A):13-22. doi: 10.1016/0002-9343(86)90336-0.
Results Reference
background
PubMed Identifier
7211912
Citation
Holland OB, Nixon JV, Kuhnert L. Diuretic-induced ventricular ectopic activity. Am J Med. 1981 Apr;70(4):762-8. doi: 10.1016/0002-9343(81)90530-1.
Results Reference
background
PubMed Identifier
1756765
Citation
Shintani S, Shiigai T, Tsukagoshi H. Marked hypokalemic rhabdomyolysis with myoglobinuria due to diuretic treatment. Eur Neurol. 1991;31(6):396-8. doi: 10.1159/000116702.
Results Reference
background
PubMed Identifier
6664121
Citation
Whelton PK. Diuretic-induced cardiac arrhythmias. Md State Med J. 1983 Dec;32(12):903-4. No abstract available.
Results Reference
background
PubMed Identifier
22917006
Citation
Storrow AB, Lindsell CJ, Collins SP, Diercks DB, Filippatos GS, Hiestand BC, Hollander JE, Kirk JD, Levy PD, Miller CD, Naftilan AJ, Nowak RM, Pang PS, Peacock WF, Gheorghiade M, Cleland JG, Gheorghiade M, Abraham WT, Amsterdam EA, Cleland JG, Diercks DB, Dunlap S, Ghali J, Hobbs R, Hiestand BC, Hollander JE, Douglas Kirk J, Kremastinos D, Levy PD, Lindsell CJ, McCord J, Miller CD, Naftilan AJ, Pang PS, Frank Peacock W, Storrow AB, Thohan V. Standardized reporting criteria for studies evaluating suspected acute heart failure syndromes in the emergency department. J Am Coll Cardiol. 2012 Aug 28;60(9):822-32. doi: 10.1016/j.jacc.2012.03.072.
Results Reference
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Once Versus Twice Daily Electrolyte Monitoring in CHF

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