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:
University of California, San Francisco
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 May 16, 2013