NCT06374823

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 342 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Critical Care
• Hyperchloremia
• Hemorrhagic Stroke

Interventions

Type	Name	Description
DRUG	Multiple Electrolyte	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.
DRUG	Normal Saline	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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: China