Septic ShockNCT04449757
Bicarbonated Ringer's Solution Versus Lactated Ringer's Solution in Patients With Septic Shock
A study testing Bicarbonated Ringer's solution and Lactated Ringer's solution in people with Septic Shock and Fluid Resuscitation, run by Zhongnan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Septic Shock, Fluid Resuscitation, Crystalloid Solution
- What is being tested?
- Bicarbonated Ringer's solution and Lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 7. Pregnant of breast-feeding women;
- 8. Considered inevitable death;
- 9. Other situations where investigators think enrollment is not appropriate.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Bicarbonated Ringer's solution, Lactated Ringer's solution
- Keywords
- septic shock, fluid resuscitation, crystalloid solution, intensive care unit
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicarbonated Ringer's solutionDrug
Also called Ringers Bicarbonate
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
Lactated Ringer's solutionDrug
Also called Ringers Lactate
Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
| Study group | Role | What they receive |
|---|---|---|
| bicarbonated ringer's solution | Experimental | We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock. Receives: Drug: Bicarbonated Ringer's solution |
| lactated ringer's solution | Experimental | We apply lactated ringer's solution as resuscitation fluid to patients with septic shock. Receives: Drug: Lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
the average doses of vasopressors
total doses of norepinephrine÷weight÷duration of usage
Measured: 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 outcomes (8)
the PH value
the potencial of hydrogen of arterial blood
Measured: 0, 3 hours, 6 hours, 12 hours, 24 hours
the BE value
the base excess of arterial blood
Measured: 0, 3 hours, 6 hours, 12 hours, 24 hours
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
Measured: 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 fluids before hemodynamic stabilization
total volume of bicarbonated ringers/lactated ringers before hemodynamic stabilization
Measured: 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 change of serum lactate value at the 6th hour
serum lactate (6h) - serum lactate (0h)
Measured: 6 hours
the proportion of patients whose serum lactate decreases 30%
the proportion of patients whose serum lactate decreases 30%
Measured: 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.
mortality from any cause
the rate of death from any cause within 28 days after enrollment
Measured: on the day28 after enrollment
the rate of metabolic alkalosis
the percentage of metabolic alkalosis (PH>7.45 and HCO3>26mmol/L)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 May 2021 (estimated)
- Study completion30 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhiYong Peng, Zhongnan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04449757
- Sponsor's protocol ID
- 2020044
- Status last verified
- Jun 2020
- First submitted
- 27 May 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04449757
- Acronym / sponsor ID
- 2020044
- Keywords
- septic shock, fluid resuscitation, crystalloid solution, intensive care unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 May 2021 (estimated)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bicarbonated ringer's solution | Experimental | Drug: Bicarbonated Ringer's solutionWe apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock. |
| lactated ringer's solution | Experimental | Drug: Lactated Ringer's solutionWe apply lactated ringer's solution as resuscitation fluid to patients with septic shock. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicarbonated Ringer's solutionAlso: Ringers BicarbonateMethod of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians. | Drug | bicarbonated ringer's solution |
| Lactated Ringer's solutionAlso: Ringers LactateMethod of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians. | Drug | lactated ringer's solution |
Primary outcome
the average doses of vasopressors
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.
total doses of norepinephrine÷weight÷duration of usage
8 secondary outcomes
the PH value
Time frame: 0, 3 hours, 6 hours, 12 hours, 24 hours
the BE value
Time frame: 0, 3 hours, 6 hours, 12 hours, 24 hours
shock reversal time
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.
total volume of fluids 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.
the change of serum lactate value at the 6th hour
Time frame: 6 hours
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.
mortality from any cause
Time frame: on the day28 after enrollment
the rate of metabolic alkalosis
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicarbonated Ringer's solution and Lactated Ringer's solution in people with Septic Shock and Fluid Resuscitation, run by Zhongnan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the average doses of vasopressors (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.