SODium BICarbonate for Metabolic Acidosis in the ICU

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Jan 15, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether giving sodium bicarbonate (a type of salt) to adults in the Intensive Care Unit (ICU) who have a condition called metabolic acidosis can help protect their kidneys. Metabolic acidosis happens when the body produces too much acid or when the kidneys aren't removing enough acid from the body. In this trial, researchers want to see if an infusion of sodium bicarbonate mixed with a sugar solution is better than just the sugar solution alone for preventing major kidney problems within 30 days.

To be eligible for this trial, participants must be at least 18 years old and currently receiving medication to help keep their blood pressure stable. They also need to have specific signs of metabolic acidosis. If someone meets these criteria, they may be invited to participate. Throughout the trial, participants will receive either the sodium bicarbonate solution or the sugar solution, and their health will be monitored closely. It's an important study aimed at improving care for patients in critical condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All the diagnostic criteria of metabolic acidosis below have to be fulfilled within the last 2 hours before randomisation (pH, PaCO2 and BE from the same blood gas), and a vasopressor is being infused continuously at the time of randomization.
• • 1. Adults (≥ 18 years);
• • 2. Receiving a continuous infusion of a vasopressor to maintain mean arterial pressure \> 65 mmHg (or a mean arterial pressure target set by the treating clinician);
• • 3. A dedicated intravenous line (central or peripheral) is available (or insertion of such a line is planned within the next hour); and
• 4. Metabolic acidosis, defined as:
• • 1. pH \< 7.30; and
• • 2. BE ≤ -4 mEq/L; and
• • 3. PaCO2 ≤ 45 mmHg for non-intubated patients or PaCO2 ≤ 50 mmHg for intubated patients.
• Exclusion Criteria:
• • 1. Fulfilled all eligibility criteria greater than 48 hours ago; or
• • 2. Suspected clinically significant digestive or urinary tract loss of sodium bicarbonate (e.g., diarrhoea, ileostomy losses, renal tubular acidosis, or drainage of pancreatic or bile duct); or
• • 3. DKA; or
• • 4. Estimated glomerular filtration rate (eGFR) \< 30 mL/min due to chronic kidney disease; or
• • 5. Currently receiving sodium bicarbonate at the moment of randomisation (doses of sodium bicarbonate prior to randomisation are allowed); or
• • 6. Currently receiving RRT (acute or chronic) or planned to start RRT in the next 3 hours (according to the treating clinical team); or
• • 7. Severe dysnatraemia (serum Na ≥ 155 mEq/L or \< 120 mEq/L); or
• • 8. Hypokalaemia (serum K \< 2.5 mEq/L); or
• • 9. Pulmonary oedema with PaO2 / FiO2 \< 100; or
• • 10. Hypocalcaemia (iCa \< 0.8mmol/L); or
• • 11. Patients admitted to the ICU after a drug overdose or intoxication (including alcohol intoxication); or
• • 12. Pregnancy or breastfeeding; or
• • 13. Death is deemed to be inevitable as a result of the current acute illness and either the treating clinician, the patient or the substitute decision maker are not committed to full active treatment; or
• • 14. Patients with a life expectancy \< 30 days due to a chronic or underlying medical condition; or
• • 15. Considered to be at high risk of cerebral oedema by the treating clinician (e.g. traumatic brain injury or acute brain disease); or
• • 16. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
• • 17. Previous enrolment in this study.