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

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.

Study Overview

• Status: Completed
• Conditions: Aneurysmal Subarachnoid Hemorrhage; Hyperchloremia
• Intervention / Treatment: Drug: maintenance fluid

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • ICU, Beijing Tiantan Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multiple electrolytes solution group; 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; 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.
Active Comparator: saline group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Capital Medical University
• Investigators: Principal Investigator: Zhou Jian-Xin, MD, Capital Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: October 8, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 8, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: saline; balanced crystalloids
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: KY2023-035-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No