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

Septic Shock Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04449757
• Other study ID #: 2020044
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: June 2020
• Source: Zhongnan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crystalloid Solution
• Fluid Resuscitation
• Intensive Care Unit
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Bicarbonated Ringer's solution
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
• Lactated Ringer's solution
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.

Locations

Country	Name	City	State
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongnan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	the PH value	the potencial of hydrogen of arterial blood	0, 3 hours, 6 hours, 12 hours, 24 hours
Secondary	the BE value	the base excess of arterial blood	0, 3 hours, 6 hours, 12 hours, 24 hours
Secondary	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.
Secondary	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.
Secondary	the change of serum lactate value at the 6th hour	serum lactate (6h) - serum lactate (0h)	6 hours
Secondary	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.
Secondary	mortality from any cause	the rate of death from any cause within 28 days after enrollment	on the day28 after enrollment
Secondary	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.