Once Versus Twice Daily Electrolyte Monitoring in CHF
1 other identifier
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2015
CompletedFirst Posted
Study publicly available on registry
July 14, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedSeptember 26, 2017
September 1, 2017
1.8 years
July 7, 2015
September 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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.
entire hospital stay, an expected average of 72 hours
Secondary Outcomes (3)
Cost associated with hospitalization
entire hospital stay, an expected average of 72 hours
length of stay
entire hospital stay, an expected average of 72 hours
readmission rate
1 month
Study Arms (2)
Once daily BMP
ACTIVE COMPARATORPatient in this arm will receive once daily basic metabolic panel to monitor electrolytes
Twice daily BMP
ACTIVE COMPARATORPatient in this arm will receive twice daily basic metabolic panel to monitor electrolytes
Interventions
Patients blood is collected in routine fashion for basic blood chemistries
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- First time heart failure diagnosis
- systolic blood pressure \< 90mmHg
- patients requiring inotropes (other than digoxin) or milrinone
- estimated glomerular filtration rate \<10.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Related Publications (9)
1. American Heart Association., Heart and stroke statistical update. American Heart Association: Dallas Tx. p. v.
BACKGROUNDEllison 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.
PMID: 19564550BACKGROUNDComi 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.
PMID: 4058453BACKGROUNDEvers 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.
PMID: 9489541BACKGROUNDHelfant RH. Hypokalemia and arrhythmias. Am J Med. 1986 Apr 25;80(4A):13-22. doi: 10.1016/0002-9343(86)90336-0.
PMID: 3706349BACKGROUNDHolland 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.
PMID: 7211912BACKGROUNDShintani 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.
PMID: 1756765BACKGROUNDWhelton PK. Diuretic-induced cardiac arrhythmias. Md State Med J. 1983 Dec;32(12):903-4. No abstract available.
PMID: 6664121BACKGROUNDStorrow 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.
PMID: 22917006BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher Brown, MD
Vanderbilt physician
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident Physician
Study Record Dates
First Submitted
July 7, 2015
First Posted
July 14, 2015
Study Start
October 1, 2015
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
September 26, 2017
Record last verified: 2017-09