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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01326260

Acronym

THAM

Enrollment

Registered

2011-03-30

Start date

2010-07-31

Completion date

2015-05-31

Last updated

2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resuscitation, Trauma Patients

Keywords

resuscitation, trauma, THAM, colloids, crystalloids

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results