Recruiting

Sodium Bicarbonate & THAM

Sponsor:

Mayo Clinic

Code:

NCT07424625

Conditions

Metabolic Acidosis

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Sodium bicarbonate

Tris-hydroxymethyl Aminomethane

Study Details

Brief summary:

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.

Conditions

Metabolic Acidosis

Study ID

NCT07424625

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

  • Inclusion criteria

  • Cardiothoracic surgery with use of cardiopulmonary bypass
  • Presence of metabolic acidosis (defined as a base excess of <-5)
  • Minnesota Research Authorization
  • Exclusion criteria

  • Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass
  • Absence of metabolic acidosis (metabolic acidosis being defined as a base excess of <-5)
  • Pregnant patients
  • Prisoners
  • Opt out of Minnesota Research Authorization

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Sodium bicarbonate

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nicole M. Lenort, RRT, LRT

866-265-9263Lenort.Nicole@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55901

Contacts

Nicole M. Lenort, RRT, LRT

866-265-9263

Principal Investigator:

Misty A. Radosevich, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

  • THAM
  • Sodium bicarbonate
  • metabolic acidosis
  • cardiac surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.