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NCT Number: NCT06374823

Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Multiple Electrolyte

Drug

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.

Other names: Multiple Electrolytes injection II

normal saline

Drug

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.

Other names: Sodium Chloride injection

Primary outcomes

  1. Hyperchloremia

    Time frame: At 24 hours, 48 hours, 72 hours after enrollment

    The incidence of hyperchloremia

Secondary outcomes

  1. Hyperchloremia acidosis

    Time frame: At 24 hours, 48 hours, 72 hours after enrollment

    Incidence of hyperchloremia acidosis

  2. Plasma osmolality

    Time frame: At 24 hours, 48 hours, 72 hours after enrollment

    Plasma osmolality calculate by algorithm

  3. AKI

    Time frame: recorded till day 7 after enrollment

    Incidence of acute kidney injury

  4. RRT

    Time frame: recorded till day 7 after enrollment

    Incidence of new renal replacement therapy

  5. hospital length of stay

    Time frame: recorded at discharge or 28 days after enrollment

    hospital length of stay

  6. ICU length of stay

    Time frame: recorded at ICU discharge or 28 days after enrollment

    ICU length of stay

  7. hospitalization expense

    Time frame: recorded at discharge or 28 days after enrollment

    hospitalization expense

Study contacts

Contact information is provided by the study sponsor or research team.

Jian-Xin Zhou, MD

CONTACT

[email protected]

+86 13801183875

Yuqing Duan

CONTACT

+86 13811505591

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study 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

Acronym: MERIT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2024
Registry last updated
Apr 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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