Health TrialsbyHealthPanel

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

ConditionsCritical CareHyperchloremiaHemorrhagic Stroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: Multiple ElectrolyteExperimental treatment 1 intervention
Group B: Normal SalineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hyperchloremia

The incidence of hyperchloremia

Time frame
At 24 hours, 48 hours, 72 hours after enrollment

Secondary outcomes

1

Hyperchloremia acidosis

Incidence of hyperchloremia acidosis

Time frame
At 24 hours, 48 hours, 72 hours after enrollment
2

Plasma osmolality

Plasma osmolality calculate by algorithm

Time frame
At 24 hours, 48 hours, 72 hours after enrollment
3

AKI

Incidence of acute kidney injury

Time frame
recorded till day 7 after enrollment
4

RRT

Incidence of new renal replacement therapy

Time frame
recorded till day 7 after enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Capital Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: