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

Terminated

• Conditions: Resuscitation, Trauma Patients

• Registration Number: NCT01326260
• Lead Sponsor: University of California, San Francisco

Brief 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.

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 Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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)

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Total amount of fluids and blood products used during the operative and 72 hr post-operative period.

Secondary Outcome Measures

Name	Time	Method
Intra-operative, intensive care unit and hospital mortality	From the operative procedure onset to discharge out of the ICU or expiration	Measure the the number of mortality during intra-operative and/or ICU period

Trial Locations

Locations (1)

University of California, San Francisco at San Francisco General Hospital; 🇺🇸 San Francisco, California, United States