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NCT06374823Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 19 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
342 (estimated)
First submitted
16 Apr 2024
Start date
May 2024
Primary completion date
Dec 2026
Lead sponsor
Capital Medical University
Diseases
Stroke
NCT number
NCT06374823

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 342
  • From May 2024 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving routine RRT

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Beijing Shijitan Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.