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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04449757
Other study ID # 2020044
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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