Pleth Variability Index and Fluid Management During Surgery

Fluid Management Clinical Trial

Official title:

Is Pleth Variability Index Able to Guide Fluid Management During Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816153
• Other study ID #: 2008/1
• Status: Completed
• Phase: N/A
• First received: December 30, 2008
• Last updated: December 30, 2008
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: December 2008
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major abdominal surgery

Exclusion Criteria:

• Refusal or inability to understand the protocol

• Arrythmia

• <18 years

• Contraindication to normal mechanical ventilation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fluid Management

Intervention

Other:
• PVI-guided fluid management
Peroperative comparison of standard care with PVI-guided fluid management (optimization of the PVI value with fluid loading)

Locations

Country	Name	City	State
Belgium	St-Luc Hospital	Brussels

Sponsors (2)

Lead Sponsor	Collaborator
Université Catholique de Louvain	Masimo Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamics and derived-parameters		The first 48 h	Yes
Secondary	All causes of morbi-mortality			Yes