Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374823
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-16
Brief Title:
Multiple Electrolytes Injection II and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke
Sponsor:
Capital Medical University
Organization:
Capital Medical University
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MERIT
Brief Summary:
Normal saline 09 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 154mmolL 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 312 of the total fluid intake and increase during the first 3 days of admission up to 581 resulting in heavy sodium and chloride loads
Among them normal saline 09 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 154mmolL 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 17 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
Among them normal saline 09 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 154mmolL 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 17 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None