Clinical trial NCT06374823: Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Critical Care
Hyperchloremia
Hemorrhagic Stroke
Keywords: Saline
Crystalloid Solution
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hyperchloremia
timeFrame: At 24 hours, 48 hours, 72 hours after enrollment
Secondary outcomes:
measure: Hyperchloremia acidosis
timeFrame: At 24 hours, 48 hours, 72 hours after enrollment
measure: Plasma osmolality
timeFrame: At 24 hours, 48 hours, 72 hours after enrollment
measure: AKI
timeFrame: recorded till day 7 after enrollment
measure: RRT
timeFrame: recorded till day 7 after enrollment
measure: hospital length of stay
timeFrame: recorded at discharge or 28 days after enrollment
measure: ICU length of stay
timeFrame: recorded at ICU discharge or 28 days after enrollment
measure: hospitalization expense
timeFrame: recorded at discharge or 28 days after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Shijitan Hospital
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Jian-Xin Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: