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Completed

NCT Number: NCT06076590

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

maintenance fluid

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.

Primary outcomes

  1. Hyperchloremia

    Time frame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment

    The incidence of hyperchloremia

Secondary outcomes

  1. Hyperchloremia acidosis

    Time frame: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment

    Incidence of hyperchloremia acidosis

  2. AKI

    Time frame: recorded at 24 hours, 48 hours, 72 hours after enrollment

    Incidence of acute kidney injury

  3. RRT

    Time frame: recorded at 24 hours, 48 hours, 72 hours after enrollment

    Incidence of new renal replacement therapy

  4. hospital length of stay

    Time frame: recorded at discharge or 28 days after enrollment

    hospital length of stay

  5. hospitalization expense

    Time frame: recorded at discharge or 28 days after enrollment

    money spend during this hospitalization

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 11, 2023
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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