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The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy.
The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 |
|
| Control | No Intervention | No intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Bicarbonate | Drug | Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the organ failure scores | use of SOFA score to assess the outcome 2 | Day 0 to Day 28 |
| Duration of renal replacement therapy (days) | need to renal replacement therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DAR St Eloi | Montpellier | 34000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12454534 | Background | Kellum JA, Levin N, Bouman C, Lameire N. Developing a consensus classification system for acute renal failure. Curr Opin Crit Care. 2002 Dec;8(6):509-14. doi: 10.1097/00075198-200212000-00005. | |
| 17334252 | Background | Dubin A, Menises MM, Masevicius FD, Moseinco MC, Kutscherauer DO, Ventrice E, Laffaire E, Estenssoro E. Comparison of three different methods of evaluation of metabolic acid-base disorders. Crit Care Med. 2007 May;35(5):1264-70. doi: 10.1097/01.CCM.0000259536.11943.90. |
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| ID | Term |
|---|---|
| D000138 | Acidosis |
| D012769 | Shock |
| ID | Term |
|---|---|
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D017693 | Sodium Bicarbonate |
| ID | Term |
|---|---|
| D001639 | Bicarbonates |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
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| Day 0 to Day 28 |
| Duration of mechanical ventilation and ventilatory free days (days) | duration of mechanical ventilation and ventilatory free days | Day 0 to Day 28 |
| Duration of vasopressors administration (h) | need for vasopressors and fluids using duration of vasopressor infusion (D0 to D28) | Day 0 to Day 28 |
| Hospital acquired infections (incidence) | hospital acquired infections using United States Centers for Disease Control definitions and a dedicated document | Day 0 to Day 28 |
| Amount of intravenous fluid (ml) | Day 0 to Day 2 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D007287 |
| Inorganic Chemicals |
| D017670 | Sodium Compounds |