250 Participants NeededMy employer runs this trial

THAM vs Sodium Bicarbonate for Acidosis

NM
Overseen ByNicole M. Lenort, RRT, LRT
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments, sodium bicarbonate and THAM (Tris-hydroxymethyl Aminomethane), for metabolic acidosis in patients undergoing heart surgery with cardiopulmonary bypass. Researchers aim to determine if these treatments are equally effective. Patients experiencing metabolic acidosis (a condition where excess acid accumulates in the body) during heart surgery may be suitable candidates. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, and this research seeks to understand its benefits for a broader patient population.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that sodium bicarbonate is commonly used and generally safe for treating metabolic acidosis. It is often used during surgeries and other medical procedures without major problems.

Conversely, studies indicate that THAM (tris-hydroxymethyl aminomethane) can effectively treat acidosis, particularly in situations like heart surgery. However, some side effects have been reported, including high potassium levels in the blood (hyperkalemia), low blood sugar (hypoglycemia), and breathing difficulties (ventilator depression). Additionally, if THAM leaks out of the vein, it can damage the surrounding tissue.

Both treatments offer advantages and disadvantages, and the choice often depends on the specific situation and patient needs. The FDA has approved THAM for treating acidosis, suggesting it is safe, but caution is advised due to possible side effects.12345

Why are researchers enthusiastic about this study treatment?

Tris-hydroxymethyl aminomethane (THAM) is unique because it offers a different approach to treating acidosis compared to the traditional use of sodium bicarbonate. Unlike sodium bicarbonate, which works by directly neutralizing acid, THAM acts as a buffer that helps maintain a stable pH balance in the blood without increasing carbon dioxide levels. This could potentially lead to fewer complications associated with carbon dioxide buildup. Researchers are excited about THAM because it may provide a more stable and potentially safer alternative for managing acidosis.

What evidence suggests that this trial's treatments could be effective for metabolic acidosis?

This trial will compare the effectiveness of THAM and sodium bicarbonate in treating metabolic acidosis. Research has shown that both THAM and sodium bicarbonate effectively treat metabolic acidosis, a condition where the body's acid levels are imbalanced. Participants in this trial will receive either THAM or sodium bicarbonate at random. Studies have found that THAM can correct acidosis as effectively as sodium bicarbonate but may cause fewer side effects, such as elevated carbon dioxide or sodium levels in the blood. Some evidence suggests that THAM might perform better in certain situations, such as when breathing is difficult or in severe metabolic issues. THAM is also considered a stronger buffer, helping to stabilize pH levels due to its higher pKA value, which measures its acid-neutralizing ability. Overall, both treatments effectively manage acidosis, particularly after heart surgery.12346

Who Is on the Research Team?

MA

Misty A. Radosevich, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people undergoing heart or chest surgery with a heart-lung machine who develop metabolic acidosis (a blood imbalance). Participants must give research consent. Some exclusions may apply.

Inclusion Criteria

* Inclusion criteria
I have had heart or chest surgery using a heart-lung machine.
* Presence of metabolic acidosis (defined as a base excess of \<-5)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either sodium bicarbonate or THAM to treat metabolic acidosis during cardiac surgery

Immediate (within surgery)

Immediate Follow-up

Participants are monitored for changes in pH, sodium, potassium, lactate, PaCO2, cardiac index, and MAP

2 hours

Extended Follow-up

Participants are monitored for incidence of acute kidney injury, duration of mechanical ventilation, incidence of renal replacement therapy, ICU length of stay, and hospital length of stay

7 days

What Are the Treatments Tested in This Trial?

Interventions

  • Sodium Bicarbonate
  • Tris-hydroxymethyl Aminomethane

Trial Overview

The study compares two treatments—sodium bicarbonate and THAM—to see if they work equally well in treating metabolic acidosis during cardiac surgery. Patients are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Tris-hydroxymethyl aminomethane (THAM)Experimental Treatment1 Intervention
Group II: Sodium bicarbonate (Bicarb)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

Tris-Hydroxymethyl Aminomethane (THAM) for Acidosis

Theoretically THAM will have effects to raise intracellular pH while NaBicarb will lower it. So potentially we are looking at the wrong numbers ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37075790/

Tris-Hydroxymethyl Aminomethane in Critically Ill Adults

In general, THAM corrected acidosis with an efficacy equivalent to sodium bicarbonate and did so with less hypercarbia and hypernatremia.

Successful Treatment of Tumor-Induced Lactic Acidosis ...

In this case, THAM was used successfully to treat the patient's severe metabolic acidosis, sparing the need for mechanical intubation. Following ...

The use of tris-hydroxymethyl aminomethane in ... - PMC - NIH

THAM is also thought to be a more effective buffer than NaHCO3 in the physiological range of blood pH because of a higher pKA (7.8 compared to 6.1 for NaHCO3).

Therapeutic Strategies for Acidosis: THAM vs. Sodium ...

Preclinical evidence consistently suggests that THAM may outperform sodium bicarbonate in settings of impaired ventilation, high ICP, or profound metabolic ...

The US military experience with THAM

Tris-Hydroxymethyl Aminomethane (THAM) has been proposed as an alternative or adjunctive therapy for refractory acidosis in the setting of combat trauma.