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Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01326260
First received: March 29, 2011
Last updated: October 28, 2014
Last verified: October 2014

March 29, 2011
October 28, 2014
July 2010
May 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Total amount of fluids and blood products used during the operative and 72 hr post-operative period.
Same as current
Complete list of historical versions of study NCT01326260 on ClinicalTrials.gov Archive Site
Intra-operative, intensive care unit and hospital mortality [ Time Frame: From the operative procedure onset to discharge out of the ICU or expiration ] [ Designated as safety issue: No ]
Measure the the number of mortality during intra-operative and/or ICU period
Same as current
Not Provided
Not Provided
 
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM)
Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

All patients admitted to San Francisco General Hospital from 2005 through 2009 with severe traumatic injury requiring emergent surgery who develop severe acidosis

Resuscitation, Trauma Patients
Not Provided
  • THAM Patients
    Patients who were managed with the use of THAM
  • Non-THAM Patients
    Patients who did not use THAM but were resuscitated with crystalloids and colloids and may have received sodium bicarbonate for the treatment of acidosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
1 Year to 90 Years
No
Contact: Julin F Tang, MD 415-206-5274 tangj@anesthesia.ucsf.edu
Contact: Gus Pangan, MBA (415) 206-5274 pangang@anesthesia.ucsf.edu
United States
 
NCT01326260
CHR 10-02652
No
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Julin Tang, MD University of California, San Francisco
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP