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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06076590
• Other study ID #: KY2023-035-02
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: October 2023
• Source: Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
China	ICU, Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hyperchloremia	The incidence of hyperchloremia	At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
Secondary	Hyperchloremia acidosis	Incidence of hyperchloremia acidosis	At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
Secondary	AKI	Incidence of acute kidney injury	recorded at 24 hours, 48 hours, 72 hours after enrollment
Secondary	RRT	Incidence of new renal replacement therapy	recorded at 24 hours, 48 hours, 72 hours after enrollment
Secondary	hospital length of stay	hospital length of stay	recorded at discharge or 28 days after enrollment
Secondary	hospitalization expense	money spend during this hospitalization	recorded at discharge or 28 days after enrollment