Sepsis, Septic ShockNCT04621981
Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis
A study testing Sodium Bicarbonate Ringer's Solution and Normal Saline in people with Sepsis, Septic Shock, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Sodium Bicarbonate Ringer's Solution and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2021to 30 Dec 2022
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
- aged between 18 and 80, male or female;
- Signed informed Consent (with delay within 24 hours).
Who cannot join
- Patients with hypermagnesemia;
- Patients with hypothyroidism;
- Patients predicted to die or discharged within 24 hours after admission;
- Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
- Pregnant or breast-feeding women;
- Patients who have received cardiopulmonary resuscitation；
- Patients who participated in other clinical trials within 30 days;
- Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Lina Zhang
About this study
At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.
Read the detailed description
Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma.
Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid.
Theoretically，Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Sodium Bicarbonate Ringer's Solution, Normal Saline
- Keywords
- Fluid Resuscitation, Crystalloid Solution
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate Ringer's SolutionDrug
Also called Bicarbonated Ringer's solution
This group was treated with Sodium Bicarbonate Ringer's Solution.
Normal SalineDrug
Also called physiological saline
This group was treated with normal saline.
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Ringer's Solution | Experimental | Intravenous drip, 500~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine. Receives: Drug: Sodium Bicarbonate Ringer's Solution |
| Normal Saline | Active comparator | Intravenous drip, 500~1000ml per time. Dosage depends on age、weight and symptoms.
Infusion speed: According to the department process or clinician's decision. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sequential Organ Failure Assessment(SOFA) value at 24h
ΔSOFA=SOFA24h-SOFA0h
Measured: 0 hours, 24 hours
Secondary outcomes (10)
Serum lactate clearance rate
(Serum lactete0h-serum lactate6h)/serum lactate0h
Measured: 0 hours, 6 hours
The proportion of patients with serum lactate clearance rate>30%
the proportion of patients whose serum lactate decrease by more than 30%
Measured: 0 hours, 6 hours, 24 hours
Changes in pH value over time, and the lowest pH value during hospitalization
ΔpH=pH3h/6h/24h-pH0h, and the lowest pH value during hospitalization
Measured: 0 hours, 3 hours, 6 hours, 24 hours
Changes in base residue (BE value) over time
ΔBE=BE3h/6h/24h-BE0h
Measured: 0 hours, 3 hours, 6 hours, 24 hours
Changes in serum bicarbonate(HCO3-) over time
ΔHCO3-=HCO3-3h/6h/24h-HCO3-0h
Measured: 0 hours, 3 hours, 6 hours, 24 hours
The proportion of patients with hyperchloremia
The proportion of patients with hyperchloremia at 3h and 24h.
Measured: 0 hours, 3 hours, 24 hours
Changes in SOFA score over time
ΔSOFA=SOFA24h/48h/72h-SOFA0h
Measured: 0 hours, 24 hours, 48 hours, 72 hours
Changes in APACHEII score over time
ΔAPACHEII=APACHEII24h/48h/72h-APACHEII0h
Measured: 0 hours, 24 hours, 48 hours, 72 hours
Mechanical ventilation time(h)
the length of mechanical ventilation time within 7 days
Measured: Within 7 days
The proportion of patients receiving RRT
The proportion of patients receiving RRT within 7 days
Measured: Within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start11 Mar 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Septic ShockStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lina Zhang, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621981
- Sponsor's protocol ID
- RIN005-R
- Status last verified
- Mar 2022
- First submitted
- 1 Nov 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04621981
- Acronym / sponsor ID
- RIN005-R
- Conditions
- Sepsis, Septic Shock
- Keywords
- Fluid Resuscitation, Crystalloid Solution
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 11 Mar 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 9 Nov 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.
At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.
Detailed description
Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma.
Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid.
Theoretically，Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate Ringer's Solution | Experimental | Drug: Sodium Bicarbonate Ringer's SolutionIntravenous drip, 500~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine. |
| Normal Saline | Active comparator | Drug: Normal SalineIntravenous drip, 500~1000ml per time. Dosage depends on age、weight and symptoms. Infusion speed: According to the department process or clinician's decision. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
- aged between 18 and 80, male or female;
- Signed informed Consent (with delay within 24 hours).
Key exclusion criteria (8 listed)
- Patients with hypermagnesemia;
- Patients with hypothyroidism;
- Patients predicted to die or discharged within 24 hours after admission;
- Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
- Pregnant or breast-feeding women;
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 |
|---|---|---|
| Sodium Bicarbonate Ringer's SolutionAlso: Bicarbonated Ringer's solutionThis group was treated with Sodium Bicarbonate Ringer's Solution. | Drug | Sodium Bicarbonate Ringer's Solution |
| Normal SalineAlso: physiological salineThis group was treated with normal saline. | Drug | Normal Saline |
Primary outcome
Change in Sequential Organ Failure Assessment(SOFA) value at 24h
Time frame: 0 hours, 24 hours
ΔSOFA=SOFA24h-SOFA0h
10 secondary outcomes
Serum lactate clearance rate
Time frame: 0 hours, 6 hours
The proportion of patients with serum lactate clearance rate>30%
Time frame: 0 hours, 6 hours, 24 hours
Changes in pH value over time, and the lowest pH value during hospitalization
Time frame: 0 hours, 3 hours, 6 hours, 24 hours
Changes in base residue (BE value) over time
Time frame: 0 hours, 3 hours, 6 hours, 24 hours
Changes in serum bicarbonate(HCO3-) over time
Time frame: 0 hours, 3 hours, 6 hours, 24 hours
The proportion of patients with hyperchloremia
Time frame: 0 hours, 3 hours, 24 hours
Changes in SOFA score over time
Time frame: 0 hours, 24 hours, 48 hours, 72 hours
Changes in APACHEII score over time
Time frame: 0 hours, 24 hours, 48 hours, 72 hours
Mechanical ventilation time(h)
Time frame: Within 7 days
The proportion of patients receiving RRT
Time frame: Within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
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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.
Lina Zhang principal investigator
Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Bicarbonate Ringer's Solution and Normal Saline in people with Sepsis, Septic Shock, run by Xiangya Hospital of Central South University 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 8 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 4 Apr 2022. 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?
Contact Lina Zhang (+8615874875763, zln7095@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Sequential Organ Failure Assessment(SOFA) value at 24h (time frame: 0 hours, 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 4 Apr 2022.