ICU, Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT06076590
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
The incidence of hyperchloremia
Time frame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
Incidence of hyperchloremia acidosis
Time frame: recorded at 24 hours, 48 hours, 72 hours after enrollment
Incidence of acute kidney injury
Time frame: recorded at 24 hours, 48 hours, 72 hours after enrollment
Incidence of new renal replacement therapy
Time frame: recorded at discharge or 28 days after enrollment
hospital length of stay
Time frame: recorded at discharge or 28 days after enrollment
money spend during this hospitalization
Capital Medical University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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