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Clinical Trials in China / NCT06374823
Starting soon Phase 4

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

NCT06374823 · tracked via the Priya Life Science China tracker
Sponsor
Capital Medical University
Phase
Phase 4
Started
2024-05
Last updated
2024-04-19

Condition(s) studied

Critical CareHyperchloremiaHemorrhagic Stroke

Investigational drug(s) / intervention(s)

Multiple ElectrolyteNormal Saline

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Shijitan Hospital Beijing Beijing Municipality

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06374823 on ClinicalTrials.gov ↗ ← All trials in China