Pleth Variability IndexNCT04373213
Evaluation of the Fluid Response of SARS-CoV-2 (COVID-19) Patients in Intensive Care; Pleth Variability Index
An observational study of Pleth Variability Index, run by Erzincan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pleth Variability Index
- What is being tested?
- Pleth variability index
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2020to 15 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age who have been hospitalized in the COVID 19 anesthesia intensive care unit
Who may be able to join
- Patients hospitalized in COVID 19 anesthesia intensive care unit
- Patients over the age of 18
Who cannot join
- Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pleth Variability Index
- Being tested
- Pleth variability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pleth variability indexDiagnostic test
The usefulness of Pleth variability index in predicting fluid response in patients with COVID 19
| Study group | Role | What they receive |
|---|---|---|
| Pleth variability index | Patients undergoing fluid management with Pleth variability index Receives: Diagnostic Test: Pleth variability index | |
| hemodynamic | Patients undergoing fluid management with hemodynamic findings Receives: Diagnostic Test: Pleth variability index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pleth variability index
Pleth variability index levels
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start5 May 2020 (estimated)
- Primary completion5 Jun 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pleth Variability IndexStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILKE KUPELI, Erzincan University
- Investigators
- ILKE KUPELI, Principal investigator, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373213
- Sponsor's protocol ID
- EBYU COVİD PVI
- Status last verified
- Apr 2020
- First submitted
- 30 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 24496190Claure-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.
PubMed 27484681de 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.
PubMed 27288609Piskin 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.
PubMed 29382017Liu 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.
PubMed 31068139
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fluid Response of SARS-CoV-2 (COVID-19) Patients in Intensive Care; Pleth Variability Index
- ClinicalTrials.gov ID
- NCT04373213
- Acronym / sponsor ID
- EBYU COVİD PVI
- Conditions
- Pleth Variability Index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Erzincan UniversityUniversity, hospital or other
- Study start
- 5 May 2020 (estimated)
- Primary completion
- 5 Jun 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pleth variability index | – | Diagnostic Test: Pleth variability indexPatients undergoing fluid management with Pleth variability index |
| hemodynamic | – | Diagnostic Test: Pleth variability indexPatients undergoing fluid management with hemodynamic findings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who have been hospitalized in the COVID 19 anesthesia intensive care unit
Key inclusion criteria (2 listed)
- Patients hospitalized in COVID 19 anesthesia intensive care unit
- Patients over the age of 18
Key exclusion criteria (1 listed)
- Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pleth variability indexThe usefulness of Pleth variability index in predicting fluid response in patients with COVID 19 | Diagnostic test | Pleth variability index, hemodynamic |
Primary outcome
Pleth variability index
Time frame: 1 month
Pleth variability index levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2020.
- Background: PubMed 24496190Basso 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.
- Background: PubMed 27484681Claure-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.
- Results publication: PubMed 27288609de 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.
- Results publication: PubMed 29382017Piskin 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.
- Results publication: PubMed 31068139Liu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ILKE KUPELI principal investigator
Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pleth Variability Index, run by Erzincan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ILKE KUPELI (05555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pleth variability index (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373213, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2020.