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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.

Key facts

Who runs it
Capital Medical University
Where
Beijing, ChinaSee the site
Trial code
Registry title
Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke
Status
Not yet recruiting
Phase
Phase 4
People taking part
342 people, planned
Started
May 2024
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Multiple Electrolyte
  • Normal Saline
Record updated
19 April 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a bleeding stroke (bleeding in the brain) who need fluid therapy. It compares two kinds of fluid drip.

Age
Over 18 years old
Sex
All sexes can join.
Disease stage
Bleeding stroke (cerebral hemorrhage, intraventricular hemorrhage or subarachnoid hemorrhage) confirmed by CT or MRI. Bleeding started no more than 72 hours ago.
Biomarker or test result
Blood chloride must not be above 110mmol/L before the trial.

Main reasons for not taking part

  • Bleeding under or over the brain lining caused by injury
  • Hypothalamic disease or cerebral salt wasting syndrome
  • Organ failure (such as heart, kidney or liver failure) or end-stage disease
  • Receiving routine RRT (renal replacement therapy)
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

  • Beijing Shijitan HospitalBeijing, ChinaContact: Jian-Xin Zhou, MDNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Multiple ElectrolyteTreatment being tested

    Multiple Electrolytes Injection(II): contains sodium chloride 6.799g, potassium chloride 0.2984g, calcium chloride 0.3675g, magnesium chloride 0.2033g, sodium acetate 3.266g, L-malic acid 0.671, sodium hydroxide 0.200g per 1000mL.

  • Normal SalineExisting treatment, for comparison

    Sodium chloride injection: contains sodium chloride 9.0g per 1000mL.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Comparing intravenous fluids for high blood chloride in severe bleeding strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
19 April 2024