Metabolic AcidosisPhase 4NCT07424625
A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients
A Phase 4 study testing Sodium bicarbonate and Tris-hydroxymethyl Aminomethane in people with Metabolic Acidosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Metabolic Acidosis
- What is being tested?
- Sodium bicarbonate and Tris-hydroxymethyl Aminomethane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2026to Jun 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiothoracic surgery with use of cardiopulmonary bypass
- Presence of metabolic acidosis (defined as a base excess of <-5)
- Minnesota Research Authorization
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Nicole M. Lenort, RRT, LRT, 866-265-9263
Misty A. Radosevich, MD
About this study
Official title: THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial
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
- Being tested
- Sodium bicarbonate, Tris-hydroxymethyl Aminomethane
- Keywords
- THAM, Sodium bicarbonate, metabolic acidosis, cardiac surgery
- Medical subject headings
- Acidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium bicarbonateDrug
Also called Bicarb
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 AminomethaneDrug
Also called THAM
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 group | Role | What they receive |
|---|---|---|
| Tris-hydroxymethyl aminomethane (THAM) | Experimental | Patients randomized to the THAM arm will be treated with tris-hydroxymethyl aminomethane.
Dosage: Base excess less than -5, administer 500 mL of THAM Receives: Drug: Tris-hydroxymethyl Aminomethane |
| Sodium bicarbonate (Bicarb) | Active comparator | 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 Receives: Drug: Sodium bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pH following buffer administration
pH will be measured via arterial blood gas test
Measured: Baseline, 2 hours
Secondary outcomes (13)
Change in sodium
Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)
Measured: Baseline, 2 hours
Change in potassium
Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)
Measured: Baseline, 2 hours
Change in lactate
Lactate will be measured via blood test and reported in mmol/L (millimoles per liter)
Measured: Baseline, 2 hours
Change in (arterial partial pressure of carbon dioxide) PaCO2
PaCO2 will be measured via arterial blood gas test, reported as mmHg (millimeters of mercury)
Measured: Baseline, 2 hours
Change in cardiac index
Cardiac index is determined by dividing cardiac output by body surface area, with a normal range of 2.5-4.0 L/min/m²
Measured: Baseline, 2 hours
Change in Mean arterial pressure (MAP)
Mean arterial pressure (MAP) is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100, reported as mmHg (millimeters of mercury)
Measured: Baseline, 2 hours
Change in vasopressor dosing
Measured: Baseline, 2 hours
Change in inotrope dose
Measured: Baseline, 2 hours
Duration of mechanical ventilation
Duration of mechanical ventilation will be reported in hours
Measured: 7 days
Incidence of acute kidney injury
Number of patients who develop acute kidney injury
Measured: 7 days
Incidence of renal replacement therapy
Number of patients who newly require renal replacement therapy
Measured: 7 days
ICU length of stay
Number of days patient stays in ICU
Measured: 7 days
Hospital length of stay
Number of days patient is hospitalized
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start14 Sep 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Misty Radosevich, Mayo Clinic
- Investigators
- Misty A. Radosevich, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424625
- Sponsor's protocol ID
- 25-002104
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radosevich MA, Wieruszewski PM, Wittwer ED. Tris-Hydroxymethyl Aminomethane in Critically Ill Adults: A Systematic Review. Anesth Analg. 2023 Nov 1;137(5):1007-1018. doi: 10.1213/ANE.0000000000006485. Epub 2023 Apr 19.
PubMed 37075790
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial
- ClinicalTrials.gov ID
- NCT07424625
- Acronym / sponsor ID
- 25-002104
- Conditions
- Metabolic Acidosis
- Keywords
- THAM, Sodium bicarbonate, metabolic acidosis, cardiac surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tris-hydroxymethyl aminomethane (THAM) | Experimental | Drug: Tris-hydroxymethyl AminomethanePatients randomized to the THAM arm will be treated with tris-hydroxymethyl aminomethane. Dosage: Base excess less than -5, administer 500 mL of THAM |
| Sodium bicarbonate (Bicarb) | Active comparator | Drug: Sodium bicarbonatePatients randomized to the Bicarb arm will be treated with sodium bicarbonate (Bicarb). Dosage: Base excess less than -5, administer 100 mEq of sodium bicarbonate |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium bicarbonateAlso: BicarbPatients 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. | Drug | Sodium bicarbonate (Bicarb) |
| Tris-hydroxymethyl AminomethaneAlso: THAMPatients 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. | Drug | Tris-hydroxymethyl aminomethane (THAM) |
Primary outcome
Change in pH following buffer administration
Time frame: Baseline, 2 hours
pH will be measured via arterial blood gas test
13 secondary outcomes
Change in sodium
Time frame: Baseline, 2 hours
Change in potassium
Time frame: Baseline, 2 hours
Change in lactate
Time frame: Baseline, 2 hours
Change in (arterial partial pressure of carbon dioxide) PaCO2
Time frame: Baseline, 2 hours
Change in cardiac index
Time frame: Baseline, 2 hours
Change in Mean arterial pressure (MAP)
Time frame: Baseline, 2 hours
Change in vasopressor dosing
Time frame: Baseline, 2 hours
Change in inotrope dose
Time frame: Baseline, 2 hours
Duration of mechanical ventilation
Time frame: 7 days
Incidence of acute kidney injury
Time frame: 7 days
Incidence of renal replacement therapy
Time frame: 7 days
ICU length of stay
Time frame: 7 days
Hospital length of stay
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 37075790Radosevich MA, Wieruszewski PM, Wittwer ED. Tris-Hydroxymethyl Aminomethane in Critically Ill Adults: A Systematic Review. Anesth Analg. 2023 Nov 1;137(5):1007-1018. doi: 10.1213/ANE.0000000000006485. Epub 2023 Apr 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Misty A. Radosevich, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium bicarbonate and Tris-hydroxymethyl Aminomethane in people with Metabolic Acidosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole M. Lenort, RRT, LRT (866-265-9263, Lenort.Nicole@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pH following buffer administration (time frame: Baseline, 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07424625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.