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

NCT ID: NCT06076590

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-05-31

Brief Summary

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

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Hyperchloremia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

maintenance fluid

Intervention Type: DRUG

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.

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

Group Type: ACTIVE_COMPARATOR

maintenance fluid

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• 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

Zhou Jian-Xin, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Medical University

Locations

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

KY2023-035-02

Identifier Type: -

Identifier Source: org_study_id