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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of California, San Francisco.
Recruitment status was  Recruiting
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 16, 2014