Étude de patients obèses comparant deux régimes de dose de charge de vancomycine
Étude prospective monocentrique de patients obèses comparant deux régimes de dose de charge de vancomycine
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
West Virginia
-
Charleston, West Virginia, États-Unis, 25304
- CAMC Health Systems
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Attain Therapeutic Vancomycin Concentrations.
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Reported Adverse Events (AE)
Délai: 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
Délai: 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
Délai: 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
Délai: 60 days
|
The total duration of hospitalization, measured from the time of hospital admission to discharge. |
60 days
|
|
In-hospital Mortality
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Troubles nutritionnels
- Suralimentation
- Poids
- Syndrome de réponse inflammatoire systémique
- Inflammation
- En surpoids
- Conditions pathologiques, signes et symptômes
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- État septique
- Infections
- Peptides
- Acides aminés, peptides et protéines
- Glucides
- Glycoconjuguis
- Glycopeptides
- Vancomycine
Autres numéros d'identification d'étude
- 15-120
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .