Metabolic Acidosis
Conditions
Keywords
THAM, Sodium bicarbonate, metabolic acidosis, cardiac surgery
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.
Interventions
DRUGSodium 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.
DRUGTris-hydroxymethyl Aminomethane
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pH following buffer administration | Baseline, 2 hours | pH will be measured via arterial blood gas test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sodium | Baseline, 2 hours | Sodium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) |
| Change in potassium | Baseline, 2 hours | Potassium will be measured via blood test and reported in reported in mEq/L (milliequivalents per liter) |
| Change in lactate | Baseline, 2 hours | Lactate will be measured via blood test and reported in mmol/L (millimoles per liter) |
| Change in (arterial partial pressure of carbon dioxide) PaCO2 | Baseline, 2 hours | PaCO2 will be measured via arterial blood gas test, reported as mmHg (millimeters of mercury) |
| Change in cardiac index | 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 |
| Change in Mean arterial pressure (MAP) | 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) |
| Change in vasopressor dosing | Baseline, 2 hours | — |
| Change in inotrope dose | Baseline, 2 hours | — |
| Duration of mechanical ventilation | 7 days | Duration of mechanical ventilation will be reported in hours |
| Incidence of acute kidney injury | 7 days | Number of patients who develop acute kidney injury |
| Incidence of renal replacement therapy | 7 days | Number of patients who newly require renal replacement therapy |
| ICU length of stay | 7 days | Number of days patient stays in ICU |
| Hospital length of stay | 7 days | Number of days patient is hospitalized |
Countries
United States
Contacts
CONTACTNicole M. Lenort, RRT, LRT
PRINCIPAL_INVESTIGATORMisty A. Radosevich, MD
Mayo Clinic
Outcome results
None listed