Critical CarePhase 4MERITNCT06374823
Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke
A Phase 4 study testing Multiple Electrolyte and Normal Saline in people with Critical Care and Hyperchloremia, run by Capital Medical University at 1 site in China.
Trial summary
Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Hyperchloremia, Hemorrhagic Stroke
- What is being tested?
- Multiple Electrolyte and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteChina
- Study dates
- May 2024to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of hemorrhagic stroke (cerebral hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage confirmed by CT or MRI, except for subdural or extradural hemorrhage caused by tramma)
- Patients requiring fluid therapy
- Patients over 18 years old
Who cannot join
- Hemorrhage onset more than 72hours
- Preexisting hyperchloremia(blood chloride > 110mmol/L)
- Presence of hypothalamic disease or cerebral salt wasting syndrome
- Patients who can eat by themselves
- Patients receiving routine RRT
- Patients with known allergic or adverse reactions to the liquid used
Show all 14Show fewer
- Patients with organ failure (such as heart failure, renal failure, liver failure) or end-stage disease
- Patients with autoimmune diseases, inflammatory diseases, metabolic diseases and blood diseases
- Patients with serious heart disease or arrhythmia
- Patients who are expected to have difficulty complying with the study plan or collecting data completely
- Pregnant or lactating women
- No informed consent was signed
- Patients participating in other clinical trials
- Other conditions deemed by the investigator to be ineligible for participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yuqing Duan contact
China1 site
Beijing Shijitan Hospital
Beijing, Beijing Municipality, 100038
Jian-Xin Zhou, MD, +8613801183875, zhoujx.cn@icloud.com
About this study
Official title: The Impact of Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study
Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline.
Read the detailed description
Fluid therapy remains an important part of the treatment and management of critically ill patients. An everyday fluid intake can be simplely divided into: resuscitation fluid, maintenance fluid, nutrition, blood products, drugs and drug carriers. Daily resuscitation and maintenance fluids can account for 31.2% of the total fluid intake and increase during the first 3 days of admission, up to 58.1%, resulting in heavy sodium and chloride loads.
Among them, normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs. However, the chloride concentration of normal saline (154mmol/L) is much higher than that of human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. Hyperchloremia is thought to cause acidosis, decrease in the glomerular filtration rate, impaired renal function, and even mortality. In contrast, the concentrations of balanced crystalloid solutions are more similar to those of plasma and is considered to be a better fluid choice than normal saline.
Hemorrhagic Stroke, which includes spontaneous cerebral hemorrhage and subarachnoid hemorrhage (SAH), is characterized by high mortality and disability. According to the latest studies, there are approximately 1.7 million new hemorrhagic strokes in China each year, and hemorrhagic strokes account for only 30% of all new stroke cases, but 60% of stroke deaths. There is a lack of relevant research on fluid recommendation for this population. One study of subarachnoid hemorrhage suggested that saline caused hyperchloremia, hypertonia, and positive fluid balance over 1500 mL in a large number of patients early after SAH.
Multiple electrolytes II, as a new isotonic balanced salt solution, contains a variety of cations (sodium, potassium, calcium, magnesium) and a lower chloride concentration than normal saline. A study of 30 patients demonstrated that it improved acid-base balance when used in neurosurgery. It may be a new alternative to sodium chloride solution.
- Conditions
- Critical Care, Hyperchloremia, Hemorrhagic Stroke
- Being tested
- Multiple Electrolyte, Normal Saline
- Keywords
- Saline, Crystalloid Solution
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple ElectrolyteDrug
Also called Multiple Electrolytes injection II
Patients who are randomized to multiple electrolyte group will be receiving Multiple Electrolytes injection II for 72 hours continously after inrollment as maintence and rescutation fluids. Infusion speed and volume will be determained by physicians.
Normal SalineDrug
Also called Sodium Chloride injection
Patients who are randomized to normal saline group will be receiving Sodium Chloride injection for 72 hours continously after inrollment as maintence and rescutation fluids. Infusion speed and volume will be determained by physicians.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Electrolyte | Experimental | Multiple Electrolytes Injection(II): contains sodium chloride 6.799g, potassium chloride 0.2984g, calcium chloride 0.3675g, magnesium chloride 0.2033g, sodium acetate 3.266g, L-malic acid 0.671, sodium hydroxide 0.200g per 1000mL. Receives: Drug: Multiple Electrolyte |
| Normal Saline | Active comparator | Sodium chloride injection: contains sodium chloride 9.0g per 1000mL. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperchloremia
The incidence of hyperchloremia
Measured: At 24 hours, 48 hours, 72 hours after enrollment
Secondary outcomes (7)
Hyperchloremia acidosis
Incidence of hyperchloremia acidosis
Measured: At 24 hours, 48 hours, 72 hours after enrollment
Plasma osmolality
Plasma osmolality calculate by algorithm
Measured: At 24 hours, 48 hours, 72 hours after enrollment
AKI
Incidence of acute kidney injury
Measured: recorded till day 7 after enrollment
RRT
Incidence of new renal replacement therapy
Measured: recorded till day 7 after enrollment
hospital length of stay
hospital length of stay
Measured: recorded at discharge or 28 days after enrollment
ICU length of stay
ICU length of stay
Measured: recorded at ICU discharge or 28 days after enrollment
hospitalization expense
hospitalization expense
Measured: recorded at discharge or 28 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical CareStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Xin Zhou, Capital Medical University
- Investigators
- Jian-Xin Zhou, MD, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374823
- Sponsor's protocol ID
- IIT2023-020-002
- Acronym
- MERIT
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06374823
- Acronym / sponsor ID
- MERIT / IIT2023-020-002
- Conditions
- Critical Care, Hyperchloremia, Hemorrhagic Stroke
- Keywords
- Saline, Crystalloid Solution
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Apr 2024 (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.
Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline.
Detailed description
Fluid therapy remains an important part of the treatment and management of critically ill patients. An everyday fluid intake can be simplely divided into: resuscitation fluid, maintenance fluid, nutrition, blood products, drugs and drug carriers. Daily resuscitation and maintenance fluids can account for 31.2% of the total fluid intake and increase during the first 3 days of admission, up to 58.1%, resulting in heavy sodium and chloride loads.
Among them, normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs. However, the chloride concentration of normal saline (154mmol/L) is much higher than that of human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. Hyperchloremia is thought to cause acidosis, decrease in the glomerular filtration rate, impaired renal function, and even mortality. In contrast, the concentrations of balanced crystalloid solutions are more similar to those of plasma and is considered to be a better fluid choice than normal saline.
Hemorrhagic Stroke, which includes spontaneous cerebral hemorrhage and subarachnoid hemorrhage (SAH), is characterized by high mortality and disability. According to the latest studies, there are approximately 1.7 million new hemorrhagic strokes in China each year, and hemorrhagic strokes account for only 30% of all new stroke cases, but 60% of stroke deaths. There is a lack of relevant research on fluid recommendation for this population. One study of subarachnoid hemorrhage suggested that saline caused hyperchloremia, hypertonia, and positive fluid balance over 1500 mL in a large number of patients early after SAH.
Multiple electrolytes II, as a new isotonic balanced salt solution, contains a variety of cations (sodium, potassium, calcium, magnesium) and a lower chloride concentration than normal saline. A study of 30 patients demonstrated that it improved acid-base balance when used in neurosurgery. It may be a new alternative to sodium chloride solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Electrolyte | Experimental | Drug: Multiple ElectrolyteMultiple Electrolytes Injection(II): contains sodium chloride 6.799g, potassium chloride 0.2984g, calcium chloride 0.3675g, magnesium chloride 0.2033g, sodium acetate 3.266g, L-malic acid 0.671, sodium hydroxide 0.200g per 1000mL. |
| Normal Saline | Active comparator | Drug: Normal SalineSodium chloride injection: contains sodium chloride 9.0g per 1000mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of hemorrhagic stroke (cerebral hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage confirmed by CT or MRI, except for subdural or extradural hemorrhage caused by tramma)
- Patients requiring fluid therapy
- Patients over 18 years old
Key exclusion criteria (14 listed)
- Hemorrhage onset more than 72hours
- Preexisting hyperchloremia(blood chloride > 110mmol/L)
- Presence of hypothalamic disease or cerebral salt wasting syndrome
- Patients who can eat by themselves
- Patients receiving routine RRT
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 |
|---|---|---|
| Multiple ElectrolyteAlso: Multiple Electrolytes injection IIPatients who are randomized to multiple electrolyte group will be receiving Multiple Electrolytes injection II for 72 hours continously after inrollment as maintence and rescutation fluids. Infusion speed and volume will be determained by physicians. | Drug | Multiple Electrolyte |
| Normal SalineAlso: Sodium Chloride injectionPatients who are randomized to normal saline group will be receiving Sodium Chloride injection for 72 hours continously after inrollment as maintence and rescutation fluids. Infusion speed and volume will be determained by physicians. | Drug | Normal Saline |
Primary outcome
Hyperchloremia
Time frame: At 24 hours, 48 hours, 72 hours after enrollment
The incidence of hyperchloremia
7 secondary outcomes
Hyperchloremia acidosis
Time frame: At 24 hours, 48 hours, 72 hours after enrollment
Plasma osmolality
Time frame: At 24 hours, 48 hours, 72 hours after enrollment
AKI
Time frame: recorded till day 7 after enrollment
RRT
Time frame: recorded till day 7 after enrollment
hospital length of stay
Time frame: recorded at discharge or 28 days after enrollment
ICU length of stay
Time frame: recorded at ICU discharge or 28 days after enrollment
hospitalization expense
Time frame: recorded at discharge or 28 days after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Yuqing Duan contact
Jian-Xin Zhou, MD principal investigator
Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multiple Electrolyte and Normal Saline in people with Critical Care and Hyperchloremia, run by Capital Medical 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 14 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: opening soon, as of the sponsor's last update on 19 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Xin Zhou, MD (+86 13801183875, zhoujx.cn@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperchloremia (time frame: At 24 hours, 48 hours, 72 hours after enrollment). 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 19 Apr 2024.