NCT06076590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 11, 2023

Completed
Last Updated

October 11, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

September 19, 2023

Last Update Submit

October 8, 2023

Conditions

Aneurysmal Subarachnoid HemorrhageHyperchloremia

Keywords

salinebalanced crystalloids

Outcome Measures

Primary Outcomes (1)

  • Hyperchloremia

    The incidence of hyperchloremia

    At 0 hours, 24 hours, 48 hours, 72 hours after enrollment

Secondary Outcomes (5)

  • Hyperchloremia acidosis

    At 0 hours, 24 hours, 48 hours, 72 hours after enrollment

  • AKI

    recorded at 24 hours, 48 hours, 72 hours after enrollment

  • RRT

    recorded at 24 hours, 48 hours, 72 hours after enrollment

  • hospital length of stay

    recorded at discharge or 28 days after enrollment

  • hospitalization expense

    recorded at discharge or 28 days after enrollment

Study Arms (2)

multiple electrolytes solution group

EXPERIMENTAL

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

Drug: maintenance fluid

saline group

ACTIVE COMPARATOR

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

Drug: maintenance fluid

Interventions

maintenance fluidDRUG

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.

multiple electrolytes solution groupsaline group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with aneurysmal subarachnoid hemorrhage;
  • Expected ICU stay \> 24 hours.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ICU, Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Zhou Jian-Xin, MD

    Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 11, 2023

Study Start

November 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 31, 2023

Last Updated

October 11, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)