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Not yet taking people in ChinaPhase 4

Comparing intravenous fluids for high blood chloride in severe bleeding stroke

Compares multiple electrolytes injection with normal saline in adults with severe hemorrhagic stroke.

Plain-language title generated from the registry record
Registry title: Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke

Key facts

Where
Beijing, ChinaSee the site
Phase
Phase 4

Where in China

  • Beijing Shijitan HospitalBeijing, ChinaNo longer taking part

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Trial details

Who runs it
Capital Medical University
Trial code
NCT06374823
Record updated
19 April 2024
Original description
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 full original descriptionShow less

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.

Inclusion: 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: Patients receiving routine RRT; Hemorrhage onset more than 72hours; Presence of hypothalamic disease or cerebral salt wasting syndrome; 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; Other conditions deemed by the investigator to be ineligible for participation in the study; Preexisting hyperchloremia(blood chloride > 110mmol/L); Patients who can eat by themselves; 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.

ClinicalTrials.gov NCT06374823