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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2014 by University of California, San Francisco.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01326260
First Posted: March 30, 2011
Last Update Posted: October 30, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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.

Condition
Resuscitation, Trauma Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ]
    Total amount of fluids and blood products used during the operative and 72 hr post-operative period.


Secondary Outcome Measures:
  • Intra-operative, intensive care unit and hospital mortality [ Time Frame: From the operative procedure onset to discharge out of the ICU or expiration ]
    Measure the the number of mortality during intra-operative and/or ICU period


Estimated Enrollment: 60
Study Start Date: July 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients admitted to San Francisco General Hospital from 2005 through 2009 with severe traumatic injury requiring emergent surgery who develop severe acidosis
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01326260


Contacts
Contact: Julin F Tang, MD 415-206-5274 tangj@anesthesia.ucsf.edu
Contact: Gus Pangan, MBA (415) 206-5274 pangang@anesthesia.ucsf.edu

Locations
United States, California
University of California, San Francisco at San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Julin Tang, MD    415-206-5274    tangj@anesthesia.ucsf.edu   
Contact: Gus Pangan, MBA    (415) 206-5274    pangang@anesthesia.ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Julin Tang, MD University of California, San Francisco
  More Information

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01326260     History of Changes
Other Study ID Numbers: CHR 10-02652
First Submitted: March 29, 2011
First Posted: March 30, 2011
Last Update Posted: October 30, 2014
Last Verified: October 2014

Keywords provided by University of California, San Francisco:
resuscitation
trauma
THAM
colloids
crystalloids

Additional relevant MeSH terms:
Acidosis
Acid-Base Imbalance
Metabolic Diseases