NCT04373213

Brief Summary

In this study; We aimed to investigate the role of pleth variability index, which is a noninvasive method, in showing fluid response in SARS-CoV-2 (COVID-19) patients, which we know is appropriate fluid management.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

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

April 30, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 5, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 30, 2020

Last Update Submit

April 30, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pleth variability index

    Pleth variability index levels

    1 month

Study Arms (2)

Pleth variability index

Patients undergoing fluid management with Pleth variability index

Diagnostic Test: Pleth variability index

hemodynamic

Patients undergoing fluid management with hemodynamic findings

Diagnostic Test: Pleth variability index

Interventions

The usefulness of Pleth variability index in predicting fluid response in patients with COVID 19

Pleth variability indexhemodynamic

Eligibility Criteria

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

Patients over 18 years of age who have been hospitalized in the COVID 19 anesthesia intensive care unit

You may qualify if:

  • Patients hospitalized in COVID 19 anesthesia intensive care unit
  • Patients over the age of 18

You may not qualify if:

  • Patients under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erzincan University

Erzincan, 24100, Turkey (Türkiye)

Location

Related Publications (5)

  • Basso F, Berdin G, Virzi GM, Mason G, Piccinni P, Day S, Cruz DN, Wjewodzka M, Giuliani A, Brendolan A, Ronco C. Fluid management in the intensive care unit: bioelectrical impedance vector analysis as a tool to assess hydration status and optimal fluid balance in critically ill patients. Blood Purif. 2013;36(3-4):192-9. doi: 10.1159/000356366. Epub 2013 Dec 20.

    PMID: 24496190BACKGROUND
  • Claure-Del Granado R, Mehta RL. Fluid overload in the ICU: evaluation and management. BMC Nephrol. 2016 Aug 2;17(1):109. doi: 10.1186/s12882-016-0323-6.

    PMID: 27484681BACKGROUND
  • de Oliveira OH, Freitas FG, Ladeira RT, Fischer CH, Bafi AT, Azevedo LC, Machado FR. Comparison between respiratory changes in the inferior vena cava diameter and pulse pressure variation to predict fluid responsiveness in postoperative patients. J Crit Care. 2016 Aug;34:46-9. doi: 10.1016/j.jcrc.2016.03.017. Epub 2016 Mar 30.

  • Piskin O, Oz II. Accuracy of pleth variability index compared with inferior vena cava diameter to predict fluid responsiveness in mechanically ventilated patients. Medicine (Baltimore). 2017 Nov;96(47):e8889. doi: 10.1097/MD.0000000000008889.

  • Liu T, Xu C, Wang M, Niu Z, Qi D. Reliability of pleth variability index in predicting preload responsiveness of mechanically ventilated patients under various conditions: a systematic review and meta-analysis. BMC Anesthesiol. 2019 May 8;19(1):67. doi: 10.1186/s12871-019-0744-4.

Study Officials

  • ILKE KUPELI

    Dr.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc. prof.

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 4, 2020

Study Start

May 5, 2020

Primary Completion

June 5, 2020

Study Completion

June 15, 2020

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations