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In this prospective randomized controlled trial, investigators aim to study the effects and safety of bicarbonated Ringer's solution in patients with septic shock compared with lactated ringer's solution, and provide evidence for current fluid resuscitation strategies for septic shock.
Although the latest guidelines recommend crystalloids as the first choice for the patients' fluid resuscitation, it still remains controversial that which crystalloid solution is the best choice. It is reported that balanced crystalloid can result in better outcomes than saline for critically ill patients. However, there are few studies conducted between different crystalloid solutions.
Lactated ringer's solution is the longest-used crystalloid solution. Compared with lactated ringer's solution whose anion is lactate, the anion of bicarbonate ringer's solution is bicarbonate. And lactate needs to be metabolized into bicarbonate through the mitochondria of the liver before it can play an alkalization role. Therefore, in theory, bicarbonate ringer's solution does not need to rely on liver metabolism, the onset time to maintain acid-base balance is shorter, and it may be more suitable for patients with severe acidosis. In patients with septic shock, the incidence of moderate to severe metabolic is increased. Bicarbonate ringer's solution can directly supplement the concentration of bicarbonate, while lactated ringer's solution needs to take time and be metabolized in the liver. Thus, we hypothesize that bicarbonate ringer's solution is more effective for patients with shock and metabolic acidosis than lactated ringer's solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bicarbonated ringer's solution | Experimental | We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock. |
|
| lactated ringer's solution | Experimental | We apply lactated ringer's solution as resuscitation fluid to patients with septic shock. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bicarbonated Ringer's solution | Drug | Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the average doses of vasopressors | total doses of norepinephrine÷weight÷duration of usage | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| the PH value | the potencial of hydrogen of arterial blood | 0, 3 hours, 6 hours, 12 hours, 24 hours |
| the BE value | the base excess of arterial blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | 430000 | China |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C506920 | bicarbonated Ringer's solution |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Lactated Ringer's solution | Drug | Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians. |
|
|
| 0, 3 hours, 6 hours, 12 hours, 24 hours |
| shock reversal time | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours. |
| total volume of fluids before hemodynamic stabilization | total volume of bicarbonated ringers/lactated ringers before hemodynamic stabilization | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours. |
| the change of serum lactate value at the 6th hour | serum lactate (6h) - serum lactate (0h) | 6 hours |
| the proportion of patients whose serum lactate decreases 30% | the proportion of patients whose serum lactate decreases 30% | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours. |
| mortality from any cause | the rate of death from any cause within 28 days after enrollment | on the day28 after enrollment |
| the rate of metabolic alkalosis | the percentage of metabolic alkalosis (PH>7.45 and HCO3>26mmol/L) | From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |