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Heart surgery acidosis: which drug works best?

NCT ID NCT07424625

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study compares two drugs, sodium bicarbonate and THAM, for treating metabolic acidosis in patients after heart surgery. About 250 adults who develop acidosis after using a heart-lung machine will be randomly assigned to receive one of the two drugs. The main goal is to see if the drugs are equally effective at raising blood pH levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sodium bicarbonate and THAM (tris-hydroxymethyl aminomethane)
What this could lead to
If the drugs are found to be equivalent, doctors may have a safe alternative to sodium bicarbonate for treating acidosis after heart surgery.
What could go wrong
This is a small, early-phase trial (250 patients) comparing two existing drugs, so it is unlikely to lead to a major breakthrough. The study only looks at short-term blood chemistry changes, not long-term outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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

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Conditions

The condition(s) this trial relates to.

Acidosis metabolic acidosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metabolic acidosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    Rochester, Minnesota, 55901, United States

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