Fluid ManagementNCT00816153
Pleth Variability Index and Fluid Management During Surgery
A study testing PVI-guided fluid management in people with Fluid Management, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management: dynamic parameter and non-invasive. PVI could guide fluid management during surgery and optimization of the plethysmographic-derived parameter could improve hemodynamics of the patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Management
- What is being tested?
- PVI-guided fluid management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2008to Aug 2008
- Phase
- Interventional
- 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
Who may be able to join
- Major abdominal surgery
Who cannot join
- Refusal or inability to understand the protocol
- Arrythmia
- <18 years
- Contraindication to normal mechanical ventilation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Pleth Variability Index Able to Guide Fluid Management During Surgery?
Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management: dynamic parameter and non-invasive. PVI could guide fluid management during surgery and optimization of the plethysmographic-derived parameter could improve hemodynamics of the patients.
- Conditions
- Fluid Management
- Being tested
- PVI-guided fluid management
- Keywords
- Pleth variability Index, Fluid management, Fluid management during surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI-guided fluid managementOther
Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)
| Study group | Role | What they receive |
|---|---|---|
| PVI | Experimental | PVI guided fluid management Receives: Other: PVI-guided fluid management |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics and derived-parameters
Measured: The first 48 h
Secondary outcomes (1)
All causes of morbi-mortality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startMar 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816153
- Sponsor's protocol ID
- 2008/1
- Status last verified
- Dec 2008
- First submitted
- 30 Dec 2008
- Last updated
- 31 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Pleth Variability Index Able to Guide Fluid Management During Surgery?
- ClinicalTrials.gov ID
- NCT00816153
- Acronym / sponsor ID
- 2008/1
- Conditions
- Fluid Management
- Keywords
- Pleth variability Index, Fluid management, Fluid management during surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Masimo Corporation
- Study start
- Mar 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 31 Dec 2008 (estimated)
- 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.
Pleth Variability Index (PVI) seems to be an ideal parameter to guide fluid management: dynamic parameter and non-invasive. PVI could guide fluid management during surgery and optimization of the plethysmographic-derived parameter could improve hemodynamics of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI | Experimental | Other: PVI-guided fluid managementPVI guided fluid management |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major abdominal surgery
Key exclusion criteria (4 listed)
- Refusal or inability to understand the protocol
- Arrythmia
- <18 years
- Contraindication to normal mechanical ventilation
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 |
|---|---|---|
| PVI-guided fluid managementPeroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading) | Other | PVI |
Primary outcome
Hemodynamics and derived-parameters
Time frame: The first 48 h
1 secondary outcome
All causes of morbi-mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI-guided fluid management in people with Fluid Management, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 31 Dec 2008. 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 Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamics and derived-parameters (time frame: The first 48 h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2008.