Experience
OUTCOMES RESEARCH Consortium is a non-profit Academic Research Organization. The consortium has considerable experience managing large clinical trials, including multi-center projects. The Consortium is especially interested in evaluating simple, low-risk, and inexpensive interventions that markedly improve patient outcome. The Consortium’s director, Dr. Sessler, is certified as a clinical investigator by the Association of Clinical Research Professionals (ACRP). Most other staff are certified by ACRP or similar organizations.
NIH Studies
Members of the Consortium have been continuously funded by NIH since 1987. Many of our recent grants are for the large clinical trials managed by the Department of OUTCOMES RESEARCH Consortium.
NIH Grant: Hyperinsulinemic glucose control and myocardial function during cardiac surgery
Grant Number: K23HL093056
Dates: 2010-15
NIH Grant: Perioperative cognitive protection--dexmedetomidine and cognitive reserve
Grant Number: AG 029656
Dates: 2007-12
NIH Grant: Effect of intrathecal ketorolac on mechanical hypersensitivity following surgery
Grant Number: GM 048085
Dates: 2009-11
NIH Grant: Dental anxiety, pain & melanocortin-1 receptor mutations
Grant Number: DE16064
Dates: 2004-06
NIH Grant: Multicenter trial of CPE for maxillofacial prosthetics
Grant Number: DE014543
Dates: 2003-08
NIH Grant: Oral care and respiratory pathogen colonization
Grant Number: DE 14879
Dates: 2003-05
NIH Grant: Nitrous oxide and wound infections
Grant Number: GM 061655
Dates: 2003-08
NIH Grant: Oxygen and surgical wound infections
Grant Number: GM 58273
Dates: 1998-03
NIH Grant: Wound healing and infection
Grant Number: GM 27345
Dates: 1990-95
NIH Grant: Perianesthetic thermoregulation and tremor
Grant Number: GM 39723
Dates: 1989-94
The Consortium has initiated and coordinated many large clinical studies. The reports listed below were selected from more than 350 full papers that resulted from projects that were fully or partially funded by NIH.
1. Schmied H, Kurz A, Sessler DI, Kozek S, Reiter A: Mild intraoperative hypothermia increases blood loss and allergenic transfusion requirements during total hip arthroplasty. Lancet 347:289-292, 1996
2. Kurz A, Sessler DI, Lenhardt R, for the Study of Wound Infections and Temperature Group: Perioperative normothermia to reduce theincidence of surgical-wound infection and the duration of hospitalization.N Engl J Med 334:1209-1215, 1996 [Accompanied by an editorial 334:1263-1264, 1996]
3. Sessler, DI: Perioperative hypothermia. N Engl J Med 336:730-737, 1997
4. Greif R, Akça O, Horn E-P, Kurz A, Sessler DI, for the OUTCOMES RESEARCH Consortium: Supplemental perioperative oxygen to reduce the incidence of surgical wound infection. N Engl J Med 343:161-167, 2000 [Accompanied by an editorial 342:202-204, 2000]
5. Taguchi A, Sharma N, Saleem RM, Sessler DI, Carpenter RL, Seyedsadr M, Kurz A: Selective postoperative inhibition of gastrointestinal opioid receptors. N Engl J Med 345:935-940, 2001 [Accompanied by an editorial 345:988-989, 2001]
6. Lenhardt R, Seybold T, Kimberger O, Stoiser B, Sessler DI: Local warming facilitates insertion of peripheral venous cannulae: a single-blinded prospective randomized controlled trial and a single blinded, randomized cross-over trial. Br Med J 325:409-412, 2002
7. Apfel CC, Korttila K, Abdalla M, Kerger H, Turan A, Vedder I, Zernak C, Danner K, Jokela R, Pocock SJ, Trenkler S, Kredel M, Biedler A, Sessler DI, Roewer N, on behalf of the IMPACT investigators. N Eng J Med 350:2441-2451, 2004 [Accompanied by an editorial 350:2511-2512, 2004]
8. Fleischmann E, Lenhardt R, Kurz A, Herbst F, Fülesdi B, Greif R, Sessler DI, Akça O, on behalf of the OUTCOMES RESEARCH Consortium: Nitrous oxide does not increase the risk of surgical wound infection. Lancet 366:1101-1107, 2005
9. Belda FJ, Agullera L, Garcia de la Assunción J, Alberti J, Vicente R, Ferrándiz L, Rodriguez R, Company R, Sessler DI, Agulilar G, Botello SG, Orti R, on behalf of the Spanish Reduccion de la Tasa de Infeccion Quirurgica Group: Supplemental perioperative oxygen and the risk of surgical wound infection: A randomized controlled trial. JAMA 294:2035-2042, 2005 [Accompanied by an editorial: 294:2091-2092, 2005]
10. Koch CG, Li L, Sessler DI, Figueroa P, Hoeltge GA, Mihaljevic T, Blackstone EH: Red cell storage duration and morbidity and mortality after cardiac surgery. N Eng J Med 358:1229-1239, 2008 [Accompanied by an editorial: 358:1295-1296, 2008]
11. Sessler DI, Sigl JC, Manberrg PJ, Kelley SD, Schubert A, Chamoun NG: A broadly applicable risk stratification system for predicting duration of hospitalization and mortality. Anesthesiology 113:1026-1037, 2010 [Accompanied by two editorials: 113:101-103, 2010 and 113:104-106, 2010] [With cover image.]
12. Sitzwohl C, Langheinrich A, Schober A, Kettner SC, Sessler DI, Gonano C, Weinstabl C, Krafft P: Endobronchial intubation detected by endotracheal tube insertion depth, bilateral auscultation, or observation of chest movements: A randomized trial. Br Med J 341:c594, 2010[Accompanied by an editorial: 341:c5936, 2010]
13. Myles PS, Peyton P, Silbert B, Hunt J, Rigg JRA, Sessler DI, for the ANZCA TrialsGroup Investigators: Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: A randomised trial. Br Med J 342:d1491, 2011
Investigator-initiated multi-center trials that the Consortium currently coordinates include studies of: 1) regional analgesia and cancer recurrence; 2) mild hypercapnia and wound infection; 3) supplemental postoperative oxygen and serious complications; 4) tight glucose control during cardiopulmonary bypass; and, 5) effects of transfusion triggers and red-cell storage duration on outcomes of cardiac surgery.
FDA Studies
The OUTCOMES RESEARCH Consortium has, and continues to, participate in numerous sponsored FDA trials. Among these was a Phase II trial that the Consortium designed and conducted for Adolor, Inc. The resulting manuscript was published in the New England Journal of Medicine: Taguchi A, Sharma N, Saleem RM, Sessler DI, Carpenter RL, Seyedsadr M, Kurz A: Selective postoperative inhibition of gastrointestinal opioid receptors. N Engl J Med 345:935-940, 2001 [Accompanied by an editorial 345:988-989, 2001].
The following list includes some of the FDA studies in which we have participated. OUTCOMES RESEARCH Consortium was the coordinating center for many of our 100 or more corporate grants.
Project Title: Incident of Perioperative Anaphylactic Reactions
Sponsor: Merck & Co Inc
Dates: 2011-12
Project Title: Effect of Goal- Directed Crystalloid versus Colloid Administration
Sponsor: Hospira
Dates: 2011-12
Project Title: A Multi Center Randomized open- Label SurgicalSurveillance
Sponsor: Cumberland Pharmaceutical
Dates: 2011-16
Project Title: The effects of dexmedetomidine and propofol on cerebral blood flow
Sponsor: Hospira
Dates: 2010-12
Project Title: Remifentanil versus dexmedetomidine
Sponsor: Hospira
Dates: 2010-12
Project Title: Postoperative outcomes in patients who receive dexmedetonidine
Sponsor: Hospira
Dates: 2010-12
Project Title: Temperature monitor evaluation
Sponsor: Arizant Healthcare
Dates: 2009-11
Project Title: LMA Perfect Temp vs. Forced Air Warming
Sponsor: LMA North America
Dates: 2010
Project Title: Sugammadex trial #19.4.319
Sponsor: Organon
Dates: 2009-11
Project Title: Dexlerium POCD
Sponsor: Aspect Medical
Dates: 2009-14
Project Title: BIS and long-term outcomes
Sponsor: Aspect Medical
Dates: 2009-13
Project Title: ASPECT Medical Data Collaborating Agreement
Sponsor: Aspect Medical
Dates: 2008-13
Project Title: Breast Cancer Recurrence
Sponsor: Aspect Medical
Dates: 2008-13
