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

University of California, San Francisco60 enrolled

Overview

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.

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

Conditions

Resuscitation, Trauma Patients

Eligibility

Sex: ALLMin age: 1 YearMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California, San Francisco at San Francisco General Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Intra-operative, intensive care unit and hospital mortality

Measure the the number of mortality during intra-operative and/or ICU period

Time frame: From the operative procedure onset to discharge out of the ICU or expiration

Data from ClinicalTrials.gov

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