NCT05644535

Brief Summary

The purpose of this study was to measure cerebrospinal fluid density in aged patients and to see if there was a correlation between these factors and cerebrospinal fluid density by using the electronic medical record system to understand the patient's gender, blood glucose, blood biochemical electrolytes and blood levels.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

December 1, 2022

Last Update Submit

December 8, 2022

Conditions

Keywords

Cerebrospinal fluidCorrelation AnalysisLighter Specific Gravity

Outcome Measures

Primary Outcomes (1)

  • Cerebrospinal fluid density

    After obtaining the mass of cerebrospinal fluid, the density was calculated from ρ=m/v

    baseline (before anesthesia)

Secondary Outcomes (7)

  • Blood sugar

    baseline (before anesthesia)

  • Plasma K+ concentration

    baseline (before anesthesia)

  • Plasma Cl- concentration

    baseline (before anesthesia)

  • WBC

    baseline (before anesthesia)

  • Neutrophil concentration in blood

    baseline (before anesthesia)

  • +2 more secondary outcomes

Study Arms (4)

Group A

Patients were aged 60-69 years

Diagnostic Test: Cerebrospinal fluid densitometryDiagnostic Test: blood routine examinationDiagnostic Test: Blood electrolyte examination

Group B

Patients were aged 70-79 years

Diagnostic Test: Cerebrospinal fluid densitometryDiagnostic Test: blood routine examinationDiagnostic Test: Blood electrolyte examination

Group C

Patients were aged 80-89 years

Diagnostic Test: Cerebrospinal fluid densitometryDiagnostic Test: blood routine examinationDiagnostic Test: Blood electrolyte examination

Group D

Patient age \> 90 years

Diagnostic Test: Cerebrospinal fluid densitometryDiagnostic Test: blood routine examinationDiagnostic Test: Blood electrolyte examination

Interventions

After obtaining the patient's cerebrospinal fluid specimen, the actual mass of the cerebrospinal fluid was measured by pipetting 1000 μL of cerebrospinal fluid specimen on an analytical balance using a pipette gun, and all specimens were measured three times and the average of the three times was taken as the final mass of 1000 μL of that specimen. After the mass measurement, the residual cerebrospinal fluid was disposed of as medical waste. The density of each specimen was obtained according to the density to mass conversion formula ρ=m/v.

Group AGroup BGroup CGroup D

After obtaining the patient's blood specimens, they were sent to the laboratory for blood routine examination.

Group AGroup BGroup CGroup D

After obtaining the patient's blood specimens, they were sent to the laboratory for blood electrolyte examination.

Group AGroup BGroup CGroup D

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Selected aged patients who had hip arthroplasty in our hospital between December 2022 and May 2023

You may qualify if:

  • Receiving combined spinal and epidural anesthesia or subarachnoid anesthesia ASA Ⅰ or Ⅱ patients No significant neurological pathology No recent history of cerebral infarction No recent history of cerebral hemorrhage No central nervous system inflammation No spinal inflammatory disease No history of spinal surgery Patients who have given pre-operative informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiming Zhang

Chenzhou, Hunan, 423000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid of the patient

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 9, 2022

Study Start

December 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

December 9, 2022

Record last verified: 2022-11

Locations