NCT00816153

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 31, 2008

Completed
Last Updated

December 31, 2008

Status Verified

December 1, 2008

Enrollment Period

5 months

First QC Date

December 30, 2008

Last Update Submit

December 30, 2008

Conditions

Fluid Management

Keywords

Pleth variability IndexFluid managementFluid management during surgery

Outcome Measures

Primary Outcomes (1)

  • Hemodynamics and derived-parameters

    The first 48 h

Secondary Outcomes (1)

  • All causes of morbi-mortality

Study Arms (2)

PVI

EXPERIMENTAL

PVI guided fluid management

Other: PVI-guided fluid management

Control

NO INTERVENTION

Interventions

PVI-guided fluid managementOTHER

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

PVI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major abdominal surgery

You may not qualify if:

  • Refusal or inability to understand the protocol
  • Arrythmia
  • \<18 years
  • Contraindication to normal mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St-Luc Hospital

Brussels, 1200, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 30, 2008

First Posted

December 31, 2008

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 31, 2008

Record last verified: 2008-12

Locations

BE(1)