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

Resuscitation, Trauma Patients Clinical Trial

— THAM  

Official title:

Early Aggressive Correction of Severe Acidosis With Tris-hydroxymethylaminomethane (THAM) in Patients With Severe Traumatic Injury: A Retrospective Cohort Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01326260
• Other study ID #: CHR 10-02652
• Status: Terminated
• Start date: July 2010
• Est. completion date: May 2015

Study information

• Verified date: February 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acidosis
• Resuscitation, Trauma Patients

Locations

Country	Name	City	State
United States	University of California, San Francisco at San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of fluids and blood products used during the operative and 72 hr post-operative period.	Total amount of fluids and blood products used during the operative and 72 hr post-operative period.	Operative period and ICU (72 hr) post-op period
Secondary	Intra-operative, intensive care unit and hospital mortality	Measure the the number of mortality during intra-operative and/or ICU period	From the operative procedure onset to discharge out of the ICU or expiration