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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pH following buffer administration | pH will be measured via arterial blood gas test | Baseline, 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sodium | Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) | Baseline, 2 hours |
| Change in potassium | Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole M. Lenort, RRT, LRT | Contact | 866-265-9263 | Lenort.Nicole@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Misty A. Radosevich, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37075790 | Background | 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. |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| D001639 | Bicarbonates |
| D014325 | Tromethamine |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D007287 | Inorganic Chemicals |
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|
| 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. |
|
|
| Baseline, 2 hours |
| Change in lactate | Lactate will be measured via blood test and reported in mmol/L (millimoles per liter) | 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) | 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 | 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) | Baseline, 2 hours |
| Change in vasopressor dosing | Baseline, 2 hours |
| Change in inotrope dose | Baseline, 2 hours |
| Duration of mechanical ventilation | Duration of mechanical ventilation will be reported in hours | 7 days |
| Incidence of acute kidney injury | Number of patients who develop acute kidney injury | 7 days |
| Incidence of renal replacement therapy | Number of patients who newly require renal replacement therapy | 7 days |
| ICU length of stay | Number of days patient stays in ICU | 7 days |
| Hospital length of stay | Number of days patient is hospitalized | 7 days |
| D017670 |
| Sodium Compounds |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |