- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT02046954
EVENT - Evaluation of the Influence of hTEE (EVENT)
Retrospective Matched Pair Analyses for Evaluating the Influence of Hemodynamically Focussed Transesophageal Echocardiography (hTEE) on Postoperative Outcome in Cardiosurgery Patients
Compromised tissue oxygenation during surgery may negatively influence patient outcome. Primary cause of insufficient tissue oxygenation is reduced cardiac output due to hypovolemia and/or reduced cardiac contractility. In cardiac surgery patients especially, postoperative pericardia effusion and/or tamponade may further compromise cardiac function. Today, hemodynamically instable patients are often monitored by means of pulmonal artery catheters or transpulmonary thermodilution. However, these methods only allow quantification of functional limitations. Underlying causes may be investigated by relatively recent technology through hemodynamically focussed transesophageal echocardiography (ClariTEE(R) ImaCor) that also provide the possibility of continuous monitoring. It has been reported that a training program consisting of six hours may enable physicians who are unexperienced in the field of echocardiography to apply this new method. Up to now, there is no evidence whether this methods is associated with improved postoperative outcome.
Therefore we hypothesize that continuous hemodynamically focussed transesophageal echocardiography positively influences patient outcome (primary hypothesis). Furthermore, its application may decrease hospital expenses (secondary hypothesis).
A tanulmány áttekintése
Állapot
Körülmények
Tanulmány típusa
Beiratkozás (Tényleges)
Kapcsolatok és helyek
Tanulmányi helyek
-
-
-
Berlin, Németország, 10117
- Charité Universitätsmedizin Berin
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
Inclusion Criteria:
- elective, cardiac surgery
- hemodynamic instability or placement of hTEE/PICCO (Pulse Contour Continuous Cardiac Output) /PAC (Pulmonary Arterial Catheter) within 12 hours of ICU admission
Exclusion Criteria:
- pregnant/breastfeeding women
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
---|
Study group
Patients monitored with hemodynamically focussed transesophageal echocardiography (placement within 12 hours of ICU admission)
|
Control Group
Patients receiving conventional monitoring (e.g.
transpulmonary thermodilution)
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
---|---|
Cumulative dosage of catecholamine application
Időkeret: three days beginning upon placement of device
|
three days beginning upon placement of device
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
---|---|---|
degree and duration of other vasoactive substances
Időkeret: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
|
i.e. epinephrine, levosimendan, dopamine, nitroglycerine, nitroprusside
|
degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
|
fluid balance
Időkeret: day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
|
day 1, 2 and 3, beginning upon placement of device (or icu admission in control patients, respectively)
|
|
degree and duration of lactate acidosis
Időkeret: degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
|
maximum lactate level, date/time of maximum lactate level, first date/time when lactate <20
|
degree and duration of other vasoactive substances three days beginning upon placement of device (or icu admission in control patients, respectively)
|
duration of postoperative ventilation
Időkeret: first postoperative day until extubation (2 days on average)
|
first postoperative day until extubation (2 days on average)
|
|
incidence of renal failure
Időkeret: three days beginning upon placement of device (or icu admission in control patients, respectively)
|
analysis of creatinine plasma level
|
three days beginning upon placement of device (or icu admission in control patients, respectively)
|
incidence of hemodialysis
Időkeret: three days beginning upon placement of device (or icu admission in control patients, respectively)
|
three days beginning upon placement of device (or icu admission in control patients, respectively)
|
|
length of hospital stay
Időkeret: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
in-hospital mortality
Időkeret: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
|
cost of hospital stay
Időkeret: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
participants will be followed for the duration of hospital stay, an expected average of 3 weeks
|
Együttműködők és nyomozók
Szponzor
Publikációk és hasznos linkek
Általános kiadványok
- Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
- Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.
- Vincent JL, Rhodes A, Perel A, Martin GS, Della Rocca G, Vallet B, Pinsky MR, Hofer CK, Teboul JL, de Boode WP, Scolletta S, Vieillard-Baron A, De Backer D, Walley KR, Maggiorini M, Singer M. Clinical review: Update on hemodynamic monitoring--a consensus of 16. Crit Care. 2011 Aug 18;15(4):229. doi: 10.1186/cc10291.
- Hamilton MA, Cecconi M, Rhodes A. A systematic review and meta-analysis on the use of preemptive hemodynamic intervention to improve postoperative outcomes in moderate and high-risk surgical patients. Anesth Analg. 2011 Jun;112(6):1392-402. doi: 10.1213/ANE.0b013e3181eeaae5. Epub 2010 Oct 21.
- Giglio MT, Marucci M, Testini M, Brienza N. Goal-directed haemodynamic therapy and gastrointestinal complications in major surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2009 Nov;103(5):637-46. doi: 10.1093/bja/aep279.
- Dalfino L, Giglio MT, Puntillo F, Marucci M, Brienza N. Haemodynamic goal-directed therapy and postoperative infections: earlier is better. A systematic review and meta-analysis. Crit Care. 2011 Jun 24;15(3):R154. doi: 10.1186/cc10284.
- Cheitlin MD, Armstrong WF, Aurigemma GP, Beller GA, Bierman FZ, Davis JL, Douglas PS, Faxon DP, Gillam LD, Kimball TR, Kussmaul WG, Pearlman AS, Philbrick JT, Rakowski H, Thys DM, Antman EM, Smith SC Jr, Alpert JS, Gregoratos G, Anderson JL, Hiratzka LF, Faxon DP, Hunt SA, Fuster V, Jacobs AK, Gibbons RJ, Russell RO; ACC; AHA; ASE. ACC/AHA/ASE 2003 Guideline Update for the Clinical Application of Echocardiography: summary article. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/ASE Committee to Update the 1997 Guidelines for the Clinical Application of Echocardiography). J Am Soc Echocardiogr. 2003 Oct;16(10):1091-110. doi: 10.1016/S0894-7317(03)00685-0. No abstract available.
- Futier E, Constantin JM, Petit A, Chanques G, Kwiatkowski F, Flamein R, Slim K, Sapin V, Jaber S, Bazin JE. Conservative vs restrictive individualized goal-directed fluid replacement strategy in major abdominal surgery: A prospective randomized trial. Arch Surg. 2010 Dec;145(12):1193-200. doi: 10.1001/archsurg.2010.275.
- Grocott MPW, Mythen MG, Gan TJ. Perioperative fluid management and clinical outcomes in adults. Anesth Analg. 2005 Apr;100(4):1093-1106. doi: 10.1213/01.ANE.0000148691.33690.AC.
- Benjamin E, Griffin K, Leibowitz AB, Manasia A, Oropello JM, Geffroy V, DelGiudice R, Hufanda J, Rosen S, Goldman M. Goal-directed transesophageal echocardiography performed by intensivists to assess left ventricular function: comparison with pulmonary artery catheterization. J Cardiothorac Vasc Anesth. 1998 Feb;12(1):10-5. doi: 10.1016/s1053-0770(98)90048-9.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- EA1/249/13
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .