Non-Invasive Shock: Differentiating Shock in the Emergency Department (NIS)
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
Shock is a common final pathway for many disease states, occurring when oxygen and nutrient delivery are not sufficient to maintain normal cellular function. The incidence of shock in the emergency department (ED) is approximated to be 1-3% of ED patients(1), and it carries a high mortality, ranging from 20-50% depending on the underlying cause of shock(2). Early recognition and treatment of shock significantly improves outcomes in critically ill patients(2, 3), and so the majority of efforts to this point have focused on identifying patients with shock.
The many etiologies of shock may be grouped into several broader categories: cardiogenic, distributive, hemorrhagic, hypovolemic, anaphylactic, and neurogenic. These categories cause shock through different mechanisms, but they have a significant amount of clinical overlap (4-7), making differentiating the cause of shock challenging for the emergency provider. While some overlap also exists between the treatments for these categories, several have vastly different therapeutic approaches. Since the early treatment of shock influences outcomes(2, 3, 8, 9), identifying the correct etiology to treat should logically impact outcomes as well, although this has not been studied in shock patients. However, Moore, et al., did show that physicians were only able to correctly identify the cause of hypotension in 25% of hypotensive patients in the ED, speaking to both the difficulty in diagnosing shock etiologies and the high percentage of patients with undifferentiated shock(10).
Recently, a number of different devices and biomarkers have been suggested to have clinical utility in differentiating shock and guiding resuscitation(11-13). These devices have potential to aid in the differentiation of shock.
We will conduct a prospective, observational study of patients found to have shock and "near-shock" physiology in the emergency department. We will identify patients meeting our inclusion criteria which will identify shock and "near shock" patients. Inclusion criteria will include: HR > 120, SBP < 90, or a shock index (HR/SBP) > 1 for at least five minutes. Patients that do meet vital sign requirements, but have a lactate > 4 mmol/L, will also be included.
Enrolled patients will undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), and extremity temperature device, as well as a blood draw for biomarker assessment.
Opintotyyppi
Ilmoittautuminen (Odotettu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Massachusetts
-
Boston, Massachusetts, Yhdysvallat, 02215
- Beth Israel Deaconess Medical Center
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
- 18 years old
- determined to have shock physiology, which will be defined by vital sign requirements including SBP < 90 despite appropriate resuscitation (e.g 2 L of normal saline) for at least five minutes.
- Patients that do meet vital sign requirements and vasopressor initiation will also be included
Exclusion Criteria:
- patients determined to have atrial fibrillation with rapid ventricular response or supraventricular tachycardia, and the patient is discharged when the ventricular rate is corrected.
- Patients will also be excluded if found to have to alcohol withdrawal, intoxication, or psychiatric agitation without organic cause.
- Patients with SBP < 90 mm/hg who have been documented to have chronic low blood pressure and their blood pressure is at baseline
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Deterioration
Aikaikkuna: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
|
Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, mortality.
|
This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Mortality
Aikaikkuna: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
|
In-hospital mortality.
|
This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 2013P000004
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .