NCT05076929

Brief Summary

Administration of intravascular fluids is one of the methods to prevent SA-induced hypotension, but empirical intraoperative volume repletion carries the risk of fluid overload during elective surgery. Over fluid resuscitation is associated with organ dysfunction and higher mortality rate , thus, to avoid ineffective or even harmful intravascular volume expansion, it is important to have tools to predict hypotension and fluid responsiveness.

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 all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 13, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 26, 2021

Last Update Submit

September 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • mean arterial blood pressure

    15 minutes after tourniquet release

Interventions

ultrasoundDIAGNOSTIC_TEST

Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Total Knee Replacement Surgeries under Spinal Anesthesia

You may qualify if:

  • ASA grade I, II, III
  • Age 18 -65 yrs
  • Spinal Anesthesia

You may not qualify if:

  • Patient refusal
  • Patient having contraindication of Spinal Anesthesia (infection at the site of injection, spine deformity, coagulation disorders ) .
  • Known cardiac, renal, neurological, metabolic, endocrine, psychiatric, respiratory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Intracranial Hypotension

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 13, 2021

Study Start

May 28, 2021

Primary Completion

February 1, 2022

Study Completion

March 1, 2022

Last Updated

October 3, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations