NCT03843411

Brief Summary

The purpose of this study is to evaluate whether the change of stroke volume index(△SVI) induced by the rapid mini-fluid administration can predict fluid responsiveness in patients with pneumoperitoneum

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Status
withdrawn

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

February 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

February 13, 2019

Last Update Submit

January 28, 2020

Conditions

Keywords

mini-fluid challenge

Outcome Measures

Primary Outcomes (1)

  • change of stroke volume index

    record stroke volume index before and after mini-fluid challenge

    1 hours

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

receive operation that required pneumoperitoneum and FloTrac monitoring

You may qualify if:

  • receive operation that required pneumoperitoneum and FloTrac monitoring
  • ASA 1\~3
  • age between 20 to 70 year old

You may not qualify if:

  • patient who cannot understand the process and aim of the study
  • patient with arrhythmia
  • poor heart function(LVEF\<50%, severe valvular disease, CAD)
  • CKD
  • pregnant patient
  • patients allergic to voluven

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2019

First Posted

February 18, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 30, 2020

Record last verified: 2020-01