Studie van zwaarlijvige patiënten die twee vancomycine-laaddosisregimes vergelijken
Prospectief onderzoek in één centrum van zwaarlijvige patiënten waarbij twee vancomycine-laaddosisregimes worden vergeleken
Obesity alters the movement through the body of several antibiotics, including vancomycin. Based on literature to date, total body weight should be used to determine dosages and shorter dosing intervals may be needed. However, hospitals have different approaches to managing vancomycin in this patient population. The most common example is not exceeding a dose of 2,000mg of vancomycin at one time in these patients. However, some institutions including the Charleston Area Medical Center do not have a set maximum one time dose. To date, a study has not been done comparing two different dosing regimens in obese patients to determine if having a maximum dose cap is beneficial.
This research study is attempting to add to the limited existing body of literature regarding vancomycin dosing in obese patients. The investigators hypothesize that optimizing the initial or loading vancomycin dose that obese patients receive will decrease the time to target concentrations. For this study, obese adult patients will be randomized to receive either 1) a loading dose of 20 mg/kg with a maximum dose up to 2,000mg OR 2) a loading dose of 20 mg/kg with a maximum dose of up to 4,000mg. The study's primary aim is to determine differences in the time needed to achieve target vancomycin concentrations and the occurrence of adverse events.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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West Virginia
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Charleston, West Virginia, Verenigde Staten, 25304
- CAMC Health Systems
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Patients ≥18 years of age who present to the Charleston Area Medical Center-Memorial Hospital Emergency Department
- Weight >100kg
- Infection requiring intravenous vancomycin and admission to Charleston Area Medical Center-Memorial Hospital
Exclusion Criteria:
- Any patient <18 years of age
- Patients on dialysis or with unstable renal function (a change of >0.5 mg/dL in SCr concentration in patients with a SCr of <2 mg/dL or a 20% change in SCr in patients with a SCr of ≥2 mg/dL)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: IV Vancomycin loading dose- higher
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 4,000mg |
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care. |
|
Experimenteel: IV Vancomycin loading dose- lower
IV Vancomycin loading dose: 20 mg/kg with a maximum dose of 2,000mg |
IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to Attain Therapeutic Vancomycin Concentrations.
Tijdsspanne: Time Frame: 20 days
|
Time to attain therapeutic vancomycin concentrations was measured in hours. Therapeutic vancomycin concentrations were set as 15-20 mg/L in patients with serious, documented Gram-positive infections (e.g., endocarditis, meningitis, pneumonia, osteomyelitis), while in patients with a lower risk of Gram-positive infections (e.g., pyelonephritis, skin/tissue structured infections), therapeutic vancomycin concentrations were defined as 10-15 mg/L. |
Time Frame: 20 days
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Participants With Reported Adverse Events (AE)
Tijdsspanne: 48 hours post initial vancomycin dose
|
Red Man's syndrome: pruritus and erythematous rash involving the face, neck, and upper torso. Red Man's syndrome is an older term for vancomycin flushing syndrome (VFS). Nephrotoxicity: increase in serum creatinine (SCr) by 0.5 mg/dL or 50% from baseline on two consecutive measurements. |
48 hours post initial vancomycin dose
|
|
Examine the Pharmacokinetic Parameter of Elimination Rate Constant (ke) Following the Loading Vancomycin Dose
Tijdsspanne: 12 hours
|
These measurements assessed the elimination rate constant of vancomycin between the two treatment regimens. Two elimination rate constants were assessed: Elimination constant at 7.5-hour trough level and Elimination constant at initial trough level. |
12 hours
|
|
Intensive Care Unit Length of Stay
Tijdsspanne: 30 days
|
The duration of time participants spent in the intensive care unit (ICU) during their hospitalization. This outcome measures the total number of days spent in the ICU, from ICU admission to discharge from ICU. |
30 days
|
|
Hospital Length of Stay
Tijdsspanne: 60 days
|
The total duration of hospitalization, measured from the time of hospital admission to discharge. |
60 days
|
|
In-hospital Mortality
Tijdsspanne: 60 days
|
The percentage of participants that died during their hospital stay. This measure assesses the mortality rate from the time of hospital admission until discharge or death. |
60 days
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Geschat)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Pathologische processen
- Voedingsstoornissen
- Overvoeding
- Lichaamsgewicht
- Systemisch ontstekingsreactiesyndroom
- Ontsteking
- Overgewicht
- Pathologische aandoeningen, tekenen en symptomen
- Voedings- en stofwisselingsziekten
- Tekenen en symptomen
- Obesitas
- Sepsis
- Infecties
- Peptiden
- Aminozuren, peptiden en eiwitten
- Koolhydraten
- Glycoconjugaten
- Glycopeptiden
- Vancomycine
Andere studie-ID-nummers
- 15-120
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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