Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock

Not Applicable

• Conditions: Septic Shock; Fluid Resuscitation; Crystalloid Solution; Intensive Care Unit
• Interventions: Drug: Bicarbonated Ringer's solution; Drug: Lactated Ringer's solution

• Registration Number: NCT04449757
• Lead Sponsor: Zhongnan Hospital

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.

Study Timeline

• Study First Submitted: 2020-05-27
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-29
• Last Update Posted: 2020-06-29
• Study Start: 2020-07-01
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
bicarbonated ringer's solution	Bicarbonated Ringer's solution	We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.
lactated ringer's solution	Lactated Ringer's solution	We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.

Primary Outcome Measures

Name	Time	Method
the average doses of vasopressors	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 doses of norepinephrine÷weight÷duration of usage

Secondary Outcome Measures

Name	Time	Method
the PH value	0, 3 hours, 6 hours, 12 hours, 24 hours	the potencial of hydrogen of arterial blood
mortality from any cause	on the day28 after enrollment	the rate of death from any cause within 28 days after enrollment
the rate of metabolic alkalosis	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 percentage of metabolic alkalosis (PH\>7.45 and HCO3\>26mmol/L)
total volume of fluids 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.	total volume of bicarbonated ringers/lactated ringers before hemodynamic stabilization
the change of serum lactate value at the 6th hour	6 hours	serum lactate (6h) - serum lactate (0h)
the BE value	0, 3 hours, 6 hours, 12 hours, 24 hours	the base excess of arterial blood
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. About 24 hours.	From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate \<2.2mmol/l, or discontinuation of vasoactive drugs
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.	the proportion of patients whose serum lactate decreases 30%

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China