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

Capital Medical University

Status and phase: Completed; Phase 4

Conditions: Aneurysmal Subarachnoid Hemorrhage; Hyperchloremia

Treatments: Drug: maintenance fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT06076590

KY2023-035-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

multiple electrolytes solution group

Experimental group

Description:

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

Treatment:

Drug: maintenance fluid

saline group

Active Comparator group

Description:

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

Treatment:

Drug: maintenance fluid