Clinical Trial: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Observational
Official Title: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study
Brief Summary: This study involved the medical record review of resuscitation records for all severely-injured trauma patients requiring emergent surgical intervention and significant acidosis from 2005 through 2009.
Detailed Summary: The study objective is to assess the efficacy of fluid resuscitation and treatment of acidosis in patients who were managed with use of amine buffer THAM (tris-hydroxymethlaminomethane) versus those who were resuscitated with crystalloids or colloids and may have have received sodium bicarbonate for the treatment of acidosis.
Sponsor: University of California, San Francisco
Current Primary Outcome: Total amount of fluids and blood products used during the operative and 72 hr post-operative period. [ Time Frame: Operative period and ICU (72 hr) post-op period ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Intra-operative, intensive care unit and hospital mortality [ Time Frame: From the operative procedure onset to discharge out of the ICU or expiration ]
Original Secondary Outcome: Same as current
Information By: University of California, San Francisco
Dates:
Date Received: March 29, 2011
Date Started: July 2010
Date Completion: May 2015
Last Updated: October 28, 2014
Last Verified: October 2014