Clinical trial NCT06076590: Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study
Official title: Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aneurysmal Subarachnoid Hemorrhage
Hyperchloremia
Keywords: saline
balanced crystalloids
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hyperchloremia
timeFrame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
Secondary outcomes:
measure: Hyperchloremia acidosis
timeFrame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
measure: AKI
timeFrame: recorded at 24 hours, 48 hours, 72 hours after enrollment
measure: RRT
timeFrame: recorded at 24 hours, 48 hours, 72 hours after enrollment
measure: hospital length of stay
timeFrame: recorded at discharge or 28 days after enrollment
measure: hospitalization expense
timeFrame: recorded at discharge or 28 days after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: ICU, Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Capital Medical University
name: Zhou Jian-Xin, MD
role: PRINCIPAL_INVESTIGATOR
References: