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

University of California San Francisco (UCSF)

Status: Terminated

Conditions: Resuscitation, Trauma Patients

Study type: Observational

Funder types: Other

Identifiers

NCT01326260

CHR 10-02652

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 to 90 years old

Volunteers: No 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

Trial design

60 participants in 2 patient groups

THAM Patients

Description:

Patients who were managed with the use of THAM

Non-THAM Patients

Description:

Patients who did not use THAM but were resuscitated with crystalloids and colloids and may have received sodium bicarbonate for the treatment of acidosis