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

This study is currently recruiting participants.
Verified June 2012 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: June 25, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: July 2013
Estimated Primary Completion Date: July 2013 (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

Ages Eligible for Study:   1 Year to 90 Years
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01326260     History of Changes
Other Study ID Numbers: CHR 10-02652
Study First Received: March 29, 2011
Last Updated: June 25, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on April 15, 2014