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

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

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.

Study Overview

• Status: Terminated
• Conditions: Resuscitation, Trauma Patients

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • University of California, San Francisco at San Francisco General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Julin Tang, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Actual): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: trauma; colloids; resuscitation; crystalloids; THAM
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis
• Other Study ID Numbers: CHR 10-02652