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

NCT06374823 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IIT2023-020-002
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Care; Hyperchloremia; Hemorrhagic Stroke

Keywords

Saline; Crystalloid Solution

Outcome Measures

Primary Outcomes (1)

• Hyperchloremia

  The incidence of hyperchloremia

  At 24 hours, 48 hours, 72 hours after enrollment

Secondary Outcomes (7)

• Hyperchloremia acidosis

  At 24 hours, 48 hours, 72 hours after enrollment

• Plasma osmolality

  At 24 hours, 48 hours, 72 hours after enrollment

• AKI

  recorded till day 7 after enrollment

• RRT

  recorded till day 7 after enrollment

• hospital length of stay

  recorded at discharge or 28 days after enrollment

Study Arms (2)

Multiple Electrolyte

EXPERIMENTAL

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.

Drug: Multiple Electrolyte

Normal Saline

ACTIVE COMPARATOR

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

Drug: Normal Saline

Interventions

Multiple Electrolyte DRUG

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.

Also known as: Multiple Electrolytes injection II

Multiple Electrolyte

Normal Saline DRUG

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.

Also known as: Sodium Chloride injection

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

Beijing Shijitan Hospital

Beijing, Beijing Municipality, 100038, China

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Interventions

Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jian-Xin Zhou, MD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Xin Zhou, MD

CONTACT

+86 13801183875; zhoujx.cn@icloud.com

Yuqing Duan

CONTACT

+86 13811505591

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)