Not yet recruiting NCT07424625
A Study of Tris-Hydroxymethyl Aminomethane (THAM) Versus Sodium Bicarbonate in Cardiac Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sodium bicarbonate, Tris-hydroxymethyl Aminomethane.
- Who it may be relevant to
- Registry conditions: Metabolic Acidosis. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
THAM VErsus Sodium BiCarbOnate In CaRdiac SuRgical PatiEnts, A PragmatiC, Comparative-effectiveness Prospective Trial
Overview
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
- 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. - Drug Tris-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.
Primary outcome measures
- Change in pH following buffer administration [Time frame: Baseline, 2 hours]
Secondary outcome measures (12)
- Change in sodium [Time frame: Baseline, 2 hours]
- Change in potassium [Time frame: Baseline, 2 hours]
- Change in lactate [Time frame: Baseline, 2 hours]
- Change in (arterial partial pressure of carbon dioxide) PaCO2 [Time frame: Baseline, 2 hours]
- Change in cardiac index [Time frame: Baseline, 2 hours]
- Change in Mean arterial pressure (MAP) [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 [Time frame: 7 days]
- Incidence of acute kidney injury [Time frame: 7 days]
- Incidence of renal replacement therapy [Time frame: 7 days]
- ICU length of stay [Time frame: 7 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Publications
- 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 37075790
Identifiers
NCT: NCT07424625 · 25-002104