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

Primary Purpose

Septic Shock, Fluid Resuscitation, Crystalloid Solution

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Bicarbonated Ringer's solution
Lactated Ringer's solution
Sponsored by
Zhongnan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring septic shock, fluid resuscitation, crystalloid solution, intensive care unit

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongnan Hospital of Wuhan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bicarbonated ringer's solution

lactated ringer's solution

Arm Description

We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.

We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.

Outcomes

Primary Outcome Measures

the average doses of vasopressors
total doses of norepinephrine÷weight÷duration of usage

Secondary Outcome Measures

the PH value
the potencial of hydrogen of arterial blood
the BE value
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
total volume of fluids before hemodynamic stabilization
total volume of bicarbonated ringers/lactated ringers before hemodynamic stabilization
the change of serum lactate value at the 6th hour
serum lactate (6h) - serum lactate (0h)
the proportion of patients whose serum lactate decreases 30%
the proportion of patients whose serum lactate decreases 30%
mortality from any cause
the rate of death from any cause within 28 days after enrollment
the rate of metabolic alkalosis
the percentage of metabolic alkalosis (PH>7.45 and HCO3>26mmol/L)

Full Information

First Posted
May 27, 2020
Last Updated
June 23, 2020
Sponsor
Zhongnan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04449757
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongnan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Fluid Resuscitation, Crystalloid Solution, Intensive Care Unit
Keywords
septic shock, fluid resuscitation, crystalloid solution, intensive care unit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bicarbonated ringer's solution
Arm Type
Experimental
Arm Description
We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.
Arm Title
lactated ringer's solution
Arm Type
Experimental
Arm Description
We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.
Intervention Type
Drug
Intervention Name(s)
Bicarbonated Ringer's solution
Other Intervention Name(s)
Ringers Bicarbonate
Intervention Description
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
Intervention Type
Drug
Intervention Name(s)
Lactated Ringer's solution
Other Intervention Name(s)
Ringers Lactate
Intervention Description
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
Primary Outcome Measure Information:
Title
the average doses of vasopressors
Description
total doses of norepinephrine÷weight÷duration of usage
Time Frame
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 Outcome Measure Information:
Title
the PH value
Description
the potencial of hydrogen of arterial blood
Time Frame
0, 3 hours, 6 hours, 12 hours, 24 hours
Title
the BE value
Description
the base excess of arterial blood
Time Frame
0, 3 hours, 6 hours, 12 hours, 24 hours
Title
shock reversal time
Description
From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs
Time Frame
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.
Title
total volume of fluids before hemodynamic stabilization
Description
total volume of bicarbonated ringers/lactated ringers before hemodynamic stabilization
Time Frame
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.
Title
the change of serum lactate value at the 6th hour
Description
serum lactate (6h) - serum lactate (0h)
Time Frame
6 hours
Title
the proportion of patients whose serum lactate decreases 30%
Description
the proportion of patients whose serum lactate decreases 30%
Time Frame
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.
Title
mortality from any cause
Description
the rate of death from any cause within 28 days after enrollment
Time Frame
on the day28 after enrollment
Title
the rate of metabolic alkalosis
Description
the percentage of metabolic alkalosis (PH>7.45 and HCO3>26mmol/L)
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Zhongnan Hospital of Wuhan University
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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