Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)
Information source: University of California, San Francisco
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Resuscitation, Trauma Patients
Phase: N/A
Status: Recruiting
Sponsored by: University of California, San Francisco Official(s) and/or principal investigator(s):
Julin Tang, MD, Principal Investigator, Affiliation: University of California, San Francisco
Overall contact:
Julin F Tang, MD, Phone: 415-206-5274, Email: tangj@anesthesia.ucsf.edu
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.
Clinical Details
Official title: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
Secondary outcome: Intra-operative, intensive care unit and hospital mortality
Detailed description:
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.
Eligibility
Minimum age: 1 Year.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Presence of severe traumatic injury requiring emergent surgery
- Peri-operative development of severe acidosis (defined arterial ph less than or equal
to 7. 20 or base deficit greater than or equal to 10 mEq/dL)
- Acidosis was treated with either THAM or "usual care" (defined as crystalloid either
or without sodium bicarbonate)
Exclusion Criteria:
- None
Locations and Contacts
Julin F Tang, MD, Phone: 415-206-5274, Email: tangj@anesthesia.ucsf.edu
University of California, San Francisco at San Francisco General Hospital, San Francisco, California 94110, United States; Recruiting
Julin Tang, MD, Phone: 415-206-5274, Email: tangj@anesthesia.ucsf.edu
Gus Pangan, MBA, Phone: (415) 206-5274, Email: pangang@anesthesia.ucsf.edu
Additional Information
Starting date: July 2010
Last updated: June 25, 2012
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