Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study

Study Overview
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Brief Summary
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The goal of this pilot randomized trial is to compare the effect of Multiple Electrolytes Injection Ⅱand saline on the occurrence of hyperchloremia within 72h of randomization in patients with aneurysmal subarachnoid hemorrhage(aSAH). A secondary aim was to provide data for the design and power of a large-scale, multicenter, randomized controlled trial.

Detailed Description
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Background: The isotonic solutions commonly used in ICUs are saline (0.9% sodium chloride) and balanced crystalloid solutions (Ringer's solution, multiple electrolytes injection, etc.). Studies have shown that the lower chloride in balanced crystalloids compared to saline may result in lower risks of hyperchloremia, acute kidney injury and poor clinical outcome in critical ill patients. As a balanced crystalloid, few evidence was found on multiple electrolytes solution II in patients with aneurysmal subarachnoid hemorrhage (aSAH). Purpose This study aimed to evaluate the security and feasibility of the study. Moreover, compare the impact of multiple electrolytes injection and saline solution on hyperchloremia in aSAH patients. Method As a pilot trial of a prospective randomized controlled study, patients with aneurysmal subarachnoid hemorrhage randomly assigned to receive saline or multiple electrolytes injection II as maintenance fluid for 3 days during ICU stay.

Official Title
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Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study

Conditions
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Aneurysmal Subarachnoid Hemorrhage, Hyperchloremia

Intervention / Treatment
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* Drug: maintenance fluid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with aneurysmal subarachnoid hemorrhage; Expected ICU stay > 24 hours. Exclusion Criteria: Under 18 years of age; Pregnancy; Patients at imminent risk for death within 24 hours; Patients with a known history of serious cardiovascular, respiratory, kidney, liver, blood, or immune disease; Azotemia (BUN > 200μmol/L), hypokalemia (blood potassium < 2.5mmol/L), hypocalcemia (blood calcium < 1.8mmol/L); Patients routinely receiving renal replacement therapy (RRT); Declined to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: multiple electrolytes solution group<br>Experimental group drugs: Multiple Electrolytes Injection(II) Manufacturer: B.Braun Melsungen AG Dosage Form: Liquid Specification: 500ml/ bag Ingredients: Per 1000ml 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 Duration :36 months Storage conditions: airtight storage, storage temperature shall not exceed 25, can not be refrigerated or frozen | Drug: maintenance fluid<br>* Patients are randomized to receive ether Multiple electrolytes injection II or Normal Saline for maintenance fluid during the 72 hours after enrollment. Resuscitation fluids and fluids used for drug delivery are not limited.<br>|
| Active Comparator: saline group<br>Control group drug: Sodium chloride injection Manufacturer: Hua Run Shuang He Pharmaceutical Co., LTD. Dosage Form: Liquid Specification: 500ml:4.5g Ingredients: Per 1000ml contains sodium chloride 9.0g Duration: 36 months Storage conditions: airtight storage | Drug: maintenance fluid<br>* Patients are randomized to receive ether Multiple electrolytes injection II or Normal Saline for maintenance fluid during the 72 hours after enrollment. Resuscitation fluids and fluids used for drug delivery are not limited.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperchloremia | The incidence of hyperchloremia | At 0 hours, 24 hours, 48 hours, 72 hours after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hyperchloremia acidosis | Incidence of hyperchloremia acidosis | At 0 hours, 24 hours, 48 hours, 72 hours after enrollment | 
| AKI | Incidence of acute kidney injury | recorded at 24 hours, 48 hours, 72 hours after enrollment | 
| RRT | Incidence of new renal replacement therapy | recorded at 24 hours, 48 hours, 72 hours after enrollment | 
| hospital length of stay | hospital length of stay | recorded at discharge or 28 days after enrollment | 
| hospitalization expense | money spend during this hospitalization | recorded at discharge or 28 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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saline, balanced crystalloids