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NCT Number: NCT07424625

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

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.

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Key information

Conditions

Metabolic Acidosis Acid-Base Imbalance Acidosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Sodium bicarbonate

Drug

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.

Other names: Bicarb

Tris-hydroxymethyl Aminomethane

Drug

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.

Other names: THAM

Primary outcomes

  1. Change in pH following buffer administration

    Time frame: Baseline, 2 hours

    pH will be measured via arterial blood gas test

Secondary outcomes

  1. Change in sodium

    Time frame: Baseline, 2 hours

    Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)

  2. Change in potassium

    Time frame: Baseline, 2 hours

    Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)

  3. Change in lactate

    Time frame: Baseline, 2 hours

    Lactate will be measured via blood test and reported in mmol/L (millimoles per liter)

  4. Change in (arterial partial pressure of carbon dioxide) PaCO2

    Time frame: Baseline, 2 hours

    PaCO2 will be measured via arterial blood gas test, reported as mmHg (millimeters of mercury)

  5. Change in cardiac index

    Time frame: Baseline, 2 hours

    Cardiac index is determined by dividing cardiac output by body surface area, with a normal range of 2.5-4.0 L/min/m²

  6. Change in Mean arterial pressure (MAP)

    Time frame: Baseline, 2 hours

    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)

  7. Change in vasopressor dosing

    Time frame: Baseline, 2 hours

  8. Change in inotrope dose

    Time frame: Baseline, 2 hours

  9. Duration of mechanical ventilation

    Time frame: 7 days

    Duration of mechanical ventilation will be reported in hours

  10. Incidence of acute kidney injury

    Time frame: 7 days

    Number of patients who develop acute kidney injury

  11. Incidence of renal replacement therapy

    Time frame: 7 days

    Number of patients who newly require renal replacement therapy

  12. ICU length of stay

    Time frame: 7 days

    Number of days patient stays in ICU

  13. Hospital length of stay

    Time frame: 7 days

    Number of days patient is hospitalized

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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