A Phase 4 interventional study of Sodium bicarbonate and Tris-hydroxymethyl Aminomethane in Metabolic Acidosis, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment
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.
111 studies on the registry are indexed under Acidosis; 19 are open to participants now.
This study's planned enrollment of 250 is above the median of 52 across 79 interventional studies indexed under Acidosis.
Browse Acidosis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Cardiothoracic surgery with use of cardiopulmonary bypass
Non-cardiac surgery patients or cardiac surgery without cardiopulmonary bypass
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
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
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
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
Change in pH following buffer administration
pH will be measured via arterial blood gas test
Time frame: Baseline, 2 hours
Change in sodium
Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)
Time frame: Baseline, 2 hours
Change in potassium
Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter)
Time frame: Baseline, 2 hours
Change in lactate
Lactate will be measured via blood test and reported in mmol/L (millimoles per liter)
Time frame: 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)
Time frame: 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
Time frame: 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)
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
Duration of mechanical ventilation will be reported in hours
Time frame: 7 days
Incidence of acute kidney injury
Number of patients who develop acute kidney injury
Time frame: 7 days
Incidence of renal replacement therapy
Number of patients who newly require renal replacement therapy
Time frame: 7 days
ICU length of stay
Number of days patient stays in ICU
Time frame: 7 days
Hospital length of stay
Number of days patient is hospitalized
Time frame: 7 days
Plan to share: No
Started Sep 2026 (actual). Primary completion is estimated for Dec 2027, 15 months after the start.
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