NCT07424625

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
13mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
May 2026Aug 2027

First Submitted

Initial submission to the registry

February 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

February 14, 2026

Last Update Submit

April 22, 2026

Conditions

Metabolic Acidosis

Keywords

THAMSodium bicarbonatemetabolic acidosiscardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Change in pH following buffer administration

    pH will be measured via arterial blood gas test

    Baseline, 2 hours

Secondary Outcomes (13)

  • Change in sodium

    Baseline, 2 hours

  • Change in potassium

    Baseline, 2 hours

  • Change in lactate

    Baseline, 2 hours

  • Change in (arterial partial pressure of carbon dioxide) PaCO2

    Baseline, 2 hours

  • Change in cardiac index

    Baseline, 2 hours

  • +8 more secondary outcomes

Study Arms (2)

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

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

Drug: Sodium bicarbonate

Interventions

Sodium bicarbonateDRUG

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.

Also known as: Bicarb
Sodium bicarbonate (Bicarb)
Tris-hydroxymethyl AminomethaneDRUG

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.

Also known as: THAM
Tris-hydroxymethyl aminomethane (THAM)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Related Publications (1)

  • 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.

    PMID: 37075790BACKGROUND

MeSH Terms

Conditions

Acidosis

Interventions

Sodium BicarbonateBicarbonatesTromethamine

Condition Hierarchy (Ancestors)

Acid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CarbonatesCarbonic AcidCarbon Compounds, InorganicInorganic ChemicalsSodium CompoundsAnionsIonsElectrolytesPropylene GlycolsGlycolsAlcoholsOrganic Chemicals

Study Officials

  • Misty A. Radosevich, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole M. Lenort, RRT, LRT

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2026

First Posted

February 20, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)