Study of THAM vs. Sodium Bicarbonate for Metabolic Acidosis in Cardiac Surgery

This study is looking at two common medications, Tris-hydroxymethyl Aminomethane (THAM) and sodium bicarbonate, to see if they work similarly to treat metabolic acidosis. Metabolic acidosis is a condition where there's too much acid in your blood. This study is for patients in the intensive care unit (ICU) who have had heart surgery involving a heart-lung machine (cardiopulmonary bypass) and need treatment for metabolic acidosis. Researchers will measure the change in your blood's pH (a measure of acidity) after you receive one of these medications. The study aims to enroll 250 participants, but its current status is unclear.

Study design
This interventional study will compare two medications, THAM and sodium bicarbonate, in about 250 participants. Participants will be randomly assigned to receive one of the two medications.
What's involved
Participants will receive either sodium bicarbonate or THAM. Your pH will be measured at the start of treatment and again 2 hours later.
Compensation
Not stated in the trial record.
Follow-up
Your pH will be measured at baseline and 2 hours after receiving the medication.

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NCT07424625

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

Not Yet Recruiting
PHASE4Ages 21+InterventionalTreatment
Mayo Clinic
~250 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Sodium bicarbonateTris-hydroxymethyl Aminomethane

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pH following buffer administration
Measured over Baseline, 2 hours
Metabolic Acidosis
1 sites across 1 states
Minnesota1
  • Misty A. Radosevich, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in pH following buffer administrationBaseline, 2 hours

    pH will be measured via arterial blood gas test