- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02058940
Intravenous Exenatide in Patients With Acute Brain Injury
11 luglio 2018 aggiornato da: University of North Carolina, Chapel Hill
Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury
The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
8
Fase
- Fase 4
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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North Carolina
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Chapel Hill, North Carolina, Stati Uniti, 27599
- University of North Carolina; UNC Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Adults ≥18 years
- Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours
- Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL
- Informed consent obtained via proxy
Exclusion Criteria:
- Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females
- Type 1 diabetes mellitus
- History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)
- Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min
- Known history of gastroparesis
- History of surgery on stomach, esophagus or duodenum
- Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome
- Concurrent steroid use or planned post-operative steroid use
- History of organ transplantation
- Brain death or suspected imminent brain death within the next 72 hours
- Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention
- Currently enrolled in another investigational drug or device protocol
- Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration
- Known allergy to exenatide
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Exenatide
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50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
Lasso di tempo: Over 48 hours from infusion initiation
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Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy.
The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (<40 mg/dL) or nausea requiring exenatide discontinuation.
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Over 48 hours from infusion initiation
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Median Glucose Concentration During Exenatide Infusion
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Percentage of Glucose Measurements Within Goal Range
Lasso di tempo: Over 48 hours from infusion initiation
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Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.
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Over 48 hours from infusion initiation
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Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Glycemic Variability
Lasso di tempo: Over 48 hours from infusion initiation
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Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Median Insulin Use
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from number of insulin units administered over 48 hours starting at infusion initiation
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Over 48 hours from infusion initiation
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Percentage of Patients Requiring Rescue Insulin Infusion Protocol
Lasso di tempo: Over 48 hours from infusion initiation
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Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment
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Over 48 hours from infusion initiation
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Percentage of Hypoglycemic Episodes (<80 mg/dL)
Lasso di tempo: Over 48 hours from infusion initiation
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Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements <80 mg/dL for all patients/total number of glucose measurements collected for all patients.
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Over 48 hours from infusion initiation
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Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Percentage of Patients Experiencing Metabolic Crisis
Lasso di tempo: Over 48 hours from infusion initiation
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Metabolic crisis is defined as cerebral microdialysate glucose concentration <0.7 mmol/L in combination with lactate pyruvate ratio >40.
Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Median Daily Intracranial Pressure
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from hourly measurements starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Median Daily Cerebral Perfusion Pressure
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from hourly measurements starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Percentage of Hypotensive Episodes (SBP<100 mmHg)
Lasso di tempo: Over 48 hours from infusion initiation
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Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.
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Over 48 hours from infusion initiation
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Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)
Lasso di tempo: Over 48 hours from infusion initiation
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Calculated from blood pressure measurements starting at infusion initiation over 48 hours
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Over 48 hours from infusion initiation
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Correlation of Exenatide Concentrations With Creatinine Clearance
Lasso di tempo: Over 48 hours from infusion initiation
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Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period.
A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables.
Spearman's correlation coefficient assumes values in the range from -1 to +1, where +1 indicates the strongest possible agreement and -1 the strongest possible disagreement.
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Over 48 hours from infusion initiation
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Exenatide Elimination Rate Constant After Discontinuation of Infusion
Lasso di tempo: 24 hours
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24 hours
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Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion
Lasso di tempo: 24 hours
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24 hours
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Median Intensive Care Unit Length of Stay
Lasso di tempo: From enrollment to 30 days post study drug discontinuation
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Defined as the number of days admitted to the Intensive Care Unit
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From enrollment to 30 days post study drug discontinuation
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Median Hospital Length of Stay
Lasso di tempo: From enrollment to 30 days post study drug discontinuation
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Defined as the number of days admitted to the hospital
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From enrollment to 30 days post study drug discontinuation
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Investigatore principale: Nicole R. Pinelli, PharmD, University of North Carolina, Chapel Hill
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 agosto 2015
Completamento primario (Effettivo)
1 agosto 2017
Completamento dello studio (Effettivo)
1 agosto 2017
Date di iscrizione allo studio
Primo inviato
6 febbraio 2014
Primo inviato che soddisfa i criteri di controllo qualità
6 febbraio 2014
Primo Inserito (Stima)
10 febbraio 2014
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
12 luglio 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
11 luglio 2018
Ultimo verificato
1 settembre 2017
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Trauma craniocerebrale
- Trauma, sistema nervoso
- Lesioni cerebrali
- Ferite e lesioni
- Agenti ipoglicemizzanti
- Effetti fisiologici delle droghe
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti anti-obesità
- Incretine
- Exenatide
Altri numeri di identificazione dello studio
- 13-1391
- Astra Zeneca Pharmaceuticals (Altro numero di sovvenzione/finanziamento: D5550L00025/ISSEXEN0038)
- Medtronic MiniMed, Inc (Altro numero di sovvenzione/finanziamento: NERP14-008)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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