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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
the average doses of vasopressors
total doses of norepinephrine÷weight÷duration of usage
Time frame: 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 PH value
the potencial of hydrogen of arterial blood
Time frame: 0, 3 hours, 6 hours, 12 hours, 24 hours
the BE value
the base excess of arterial blood
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 6 hours
the proportion of patients whose serum lactate decreases 30%
the proportion of patients whose serum lactate decreases 30%
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: on the day28 after enrollment
the rate of metabolic alkalosis
the percentage of metabolic alkalosis (PH\>7.45 and HCO3\>26mmol/L)
Time frame: 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.