A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07424625
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Metabolic Acidosis

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sodium bicarbonate — DRUG
    Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass and requiring treatment for metabolic acidosis (base excess less than -5), will receive sodium bicarbonate (Bicarb) if randomized to the Bicarb arm.
  • Tris-hydroxymethyl Aminomethane — DRUG
    Patients in the ICU following cardiothoracic surgery with use of cardiopulmonary bypass, requiring treatment for metabolic acidosis (base excess less than -5), will receive tris-hydroxymethyl aminomethane (THAM) if randomized to the THAM arm.

Study Details

The purpose of this research is to determine if two commonly used medications to treat metabolic acidosis in the setting of cardiac surgery, sodium bicarbonate and THAM, are equivalent.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tris-hydroxymethyl aminomethane (THAM)
    Patients randomized to the THAM arm will be treated with tris-hydroxymethyl aminomethane. Dosage: Base excess less than -5, administer 500 mL of THAM
  • Active Comparator: Sodium bicarbonate (Bicarb)
    Patients randomized to the Bicarb arm will be treated with sodium bicarbonate (Bicarb). Dosage: Base excess less than -5, administer 100 mEq of sodium bicarbonate

Primary Outcome Measure

Change in pH following buffer administration [ Time Frame: Baseline, 2 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55901
Nicole M. Lenort, RRT, LRT
866-265-9263
Misty A. Radosevich, MD (PRINCIPAL_INVESTIGATOR)

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