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
Verified date | June 2020 |
Source | Zhongnan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhongnan Hospital of Wuhan University | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Zhongnan Hospital |
China,
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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