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

NCT ID: NCT06374823

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2026-12-31

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.

Detailed Description

Fluid therapy remains an important part of the treatment and management of critically ill patients. An everyday fluid intake can be simplely divided into: resuscitation fluid, maintenance fluid, nutrition, blood products, drugs and drug carriers. Daily resuscitation and maintenance fluids can account for 31.2% of the total fluid intake and increase during the first 3 days of admission, up to 58.1%, resulting in heavy sodium and chloride loads.

Among them, normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs. However, the chloride concentration of normal saline (154mmol/L) is much higher than that of human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. Hyperchloremia is thought to cause acidosis, decrease in the glomerular filtration rate, impaired renal function, and even mortality. In contrast, the concentrations of balanced crystalloid solutions are more similar to those of plasma and is considered to be a better fluid choice than normal saline.

Hemorrhagic Stroke, which includes spontaneous cerebral hemorrhage and subarachnoid hemorrhage (SAH), is characterized by high mortality and disability. According to the latest studies, there are approximately 1.7 million new hemorrhagic strokes in China each year, and hemorrhagic strokes account for only 30% of all new stroke cases, but 60% of stroke deaths. There is a lack of relevant research on fluid recommendation for this population. One study of subarachnoid hemorrhage suggested that saline caused hyperchloremia, hypertonia, and positive fluid balance over 1500 mL in a large number of patients early after SAH.

Multiple electrolytes II, as a new isotonic balanced salt solution, contains a variety of cations (sodium, potassium, calcium, magnesium) and a lower chloride concentration than normal saline. A study of 30 patients demonstrated that it improved acid-base balance when used in neurosurgery. It may be a new alternative to sodium chloride solution.

Conditions

Critical Care; Hyperchloremia; Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Multiple Electrolyte

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.

Group Type: EXPERIMENTAL

Multiple Electrolyte

Intervention Type: 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.

Normal Saline

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

Group Type: ACTIVE_COMPARATOR

Normal Saline

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Multiple Electrolytes injection II; Sodium Chloride injection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capital Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Xin Zhou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian-Xin Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

Beijing Shijitan Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jian-Xin Zhou, MD

Role: CONTACT

zhoujx.cn@icloud.com

+86 13801183875

Yuqing Duan

Role: CONTACT

+86 13811505591

Facility Contacts

Jian-Xin Zhou, MD

Role: primary

zhoujx.cn@icloud.com

+8613801183875

Other Identifiers

IIT2023-020-002

Identifier Type: -

Identifier Source: org_study_id