Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill
Atslēgvārdi
Abstrakts
Apraksts
- Design: randomized multiple center clinical trial, open label
- Arms: intravenous 4.2% Sodium Bicarbonate vs no additional treatment
- Inclusion: age of 18 yo or above, critically ill patient with a SOFA score of 4 or above, lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below
- Exclusion: single respiratory disorder (PaCO2 > 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24 ; acute diarrhea, ileostomy or biliary drainage ; stage IV kidney failure or chronic dialysis ; tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol) ; PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)
- Randomization: website randomization with stratification on age, presence of sepsis at inclusion, renal failure
- Intervention: experimental arm: intravenous 4.2% Sodium Bicarbonate 125 to 250ml in 30min up to 1000ml/24h. The target is a plasma pH of 7.30 or above.
- An interim statistical analysis is planned when 200 patients will be included
Datumi
| Pēdējoreiz pārbaudīts: | 02/28/2017 |
| Pirmais iesniegtais: | 06/09/2015 |
| Paredzētā reģistrācija iesniegta: | 06/17/2015 |
| Pirmais izlikts: | 06/18/2015 |
| Pēdējais atjauninājums iesniegts: | 04/19/2017 |
| Pēdējā atjaunināšana ievietota: | 04/20/2017 |
| Faktiskais studiju sākuma datums: | 05/04/2015 |
| Paredzamais primārās pabeigšanas datums: | 09/14/2017 |
| Paredzamais pētījuma pabeigšanas datums: | 10/12/2017 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Intervention
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| Experimental: Intervention Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 | Drug: Intervention Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 |
| No Intervention: Control No intervention |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - Age of 18 yo or above, - Critically ill patient with a SOFA score of 4 or above, - Lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below Exclusion Criteria: - Administration of Sodium Bicarbonate 24 hours before inclusion - Single respiratory disorder (PaCO2 > 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24 - Acute diarrhea, ileostomy or biliary drainage - Stage IV kidney failure or chronic dialysis - Tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol) - PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below) |
Rezultāts
Primārie rezultāti
1. Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4 [Day 0 to Day 28]
Sekundārie iznākuma mērījumi
1. Evolution of the organ failure scores [Day 0 to Day 28]
2. Duration of renal replacement therapy (days) [Day 0 to Day 28]
3. Duration of mechanical ventilation and ventilatory free days (days) [Day 0 to Day 28]
4. Duration of vasopressors administration (h) [Day 0 to Day 28]
5. Hospital acquired infections (incidence) [Day 0 to Day 28]
6. Amount of intravenous fluid (ml) [Day 0 to Day 2]
