Clinical trial NCT04449757: Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock
Official title: Fluid Resuscitation Management for Patients With Septic Shock: the Efficacy and Safety Comparison Between Bicarbonated Ringer's Solution and Lactated Ringer's Solution
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Septic Shock
Fluid Resuscitation
Crystalloid Solution
Intensive Care Unit
Keywords: septic shock
fluid resuscitation
crystalloid solution
intensive care unit
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1. At the age of 18 to 75;
* 2. Being treated in the ICU;
* 3. Diagnosed as septic shock according tho the definition of Sepsis 3.0 with fluid resuscitation requirement.

Exclusion Criteria:

* 1. Severe hepatic failure;
* 2. Possible brain injury;
* 3. With absolute contraindications for central vena catheterization;
* 4. Ever participated in another clinical trial within 30 days prior enrollment;
* 5. Have corrected metabolic acidosis through alkaline drug application within 24 hours prior to enrollment;
* 6. Hypermagnesemia or hypothyroidism;
* 7. Pregnant of breast-feeding women;
* 8. Considered inevitable death;
* 9. Other situations where investigators think enrollment is not appropriate.

Primary outcomes:
measure: the average doses of vasopressors
timeFrame: 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.
Secondary outcomes:
measure: the PH value
timeFrame: 0, 3 hours, 6 hours, 12 hours, 24 hours
measure: the BE value
timeFrame: 0, 3 hours, 6 hours, 12 hours, 24 hours
measure: shock reversal time
timeFrame: 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: total volume of fluids before hemodynamic stabilization
timeFrame: 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: the change of serum lactate value at the 6th hour
timeFrame: 6 hours
measure: the proportion of patients whose serum lactate decreases 30%
timeFrame: 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: mortality from any cause
timeFrame: on the day28 after enrollment
measure: the rate of metabolic alkalosis
timeFrame: 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.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References: