SODium BICarbonate for metabolic acidosis in the Intensive Care Unit: A pilot, multicentre, randomized, double-blind clinical trial
- Conditions
- Metabolic acidosisMetabolic and Endocrine - Other metabolic disordersEmergency medicine - Other emergency care
- Registration Number
- ACTRN12620001361998
- Brief Summary
In patients with metabolic acidosis (acid blood) the use of sodium bicarbonate was not associated with shorter duration of vasopressore infusion (drug to increase blood pressure). However, the use of sodium bicarbonate reduced the time until the correction of the blood pH (acidosis). These findings confirm that a larger study is feasible and needed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 30
The target population is vasopressor-dependent, adult critically ill patients, with moderate metabolic acidosis.
All the diagnostic criteria of moderate metabolic acidosis below have to be fulfilled within the last 2 hours before randomization, and a vasopressor is being infused continuously at the time of randomization.
1.Adult patients (>= 18 years);
2.Patient is within 48 hours of admission to the ICU;
3.Patient is receiving a continuous infusion of a vasopressor drug to maintain mean arterial pressure > 65 mmHg;
4.A dedicated line (central or peripheric) is available (or is about to be made available within 1 hour after randomization); and
5.Patient has at least a moderate metabolic acidosis, defined as:
a.pH < 7.30; and
b.BE < -4 mEq/L; and
c.PaCO2 < 45 mmHg.
1. Proven digestive or urinary tract loss of sodium bicarbonate (e.g., acute diarrhoea, ileostomy, or drainage of pancreatic or biliary duct); or
2. DKA; or
3. Stage IV or V chronic kidney disease; or
4. Using renal replacement therapy (acute or chronic); or
5. Received sodium bicarbonate within 24 hours of screening; or
6. Dysnatraemia (serum Na greater than or equal to 155 mEq/L or < 120 mEq/L); or
7. Hypokalaemia (serum K < 2.5 mEq/L); or
8. Pulmonary oedema with PaO2 / FiO2 < 100; or
9. Hypocalcaemia (iCa < 0.8mmol/L); or
10. Known or suspected poisoning of antidepressant or antipsychotic poisoning agents that may cause high anion gap acidosis (methanol, PEG, aspirin); or
11. Suspected intoxication with unknown aetiology; or
12. Pregnancy or breastfeeding; or
13. Limitation of medical therapy orders (DNR, DNI); or
14. Imminent or inevitable death; or
15. In the opinion of the treating clinical team the patients will almost certainly receive RRT in the next 6 hours; or
16. Traumatic brain injury (or substantial risk for intracranial hypertension); or
17. Clinician believes that being enrolled in intervention or control arm is not in the best interest of the patient; or
18. Previous enrolment in this study ever.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of hours alive and free of vasopressors at day 7 (168 hours) after randomization. This is defined as the time, censored at 7 days, that a patient was both alive and had not received vasopressors for at least 12 hours. If a patient died while receiving vasopressor therapy following the index episode, the patient is assigned zero hours for this outcome. If a patient was weaned from all vasopressors for 12 consecutive hours, then all of the remaining time through day 7 was treated as success, even if the patient died or had vasopressors restarted after weaning within the 7-day period. The outcome will be assess through patient medical records.[ 7 days (168 hours) after randomization]
- Secondary Outcome Measures
Name Time Method