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

ConditionMetabolic Acidosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

* Cardiothoracic surgery with use of cardiopulmonary bypass

Presence of metabolic acidosis (defined as a base excess of <-5)

Minnesota Research Authorization

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Tris-hydroxymethyl aminomethane (THAM)Experimental treatment 1 intervention
Group B: Sodium bicarbonate (Bicarb)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in pH following buffer administration

pH will be measured via arterial blood gas test

Time frame
Baseline, 2 hours

Secondary outcomes

1

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
2

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
3

Change in lactate

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

Time frame
Baseline, 2 hours
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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