Fluid Management Based on Pleth Variability Index (PVI) Monitoring During High-risk Surgery

NCT01788293 | Terminated DMC

• 1 other identifier: PVI - HR
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Oximetry monitoring is common practice in patients undergoing anesthesia. PVI continuous evaluation may be a possibility of agility and ease of obtaining accurate information about the state of cardiovascular responsiveness to volume expansion. This prospective and randomized study will try to demonstrate that the assessment of PVI is a simple and cost-saving method as compared to cardiac output or oxygen delivery monitoring technologies. Such a simple approach has therefore the potential for widespread application as it is not routinely feasible for anesthetists to use cardiac output or oxygen delivery monitoring technologies in many institutions, as well as in many countries.

Conditions

Fluid Loss

Keywords

Fluid management; Pleth Variability Index (PVI); monitoring; high-risk surgery

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure will be the duration of postoperative hospital stay.

  On the basis of our own hospital registry, the mean duration of postoperative hospital stay is a priori estimated at 15 ± 7 days (median ± median absolute deviation).

  An intermediate analysis after the enrolment of the first 35 patients was planed, in order to readjust the population sample size if necessary.

Secondary Outcomes (1)

• Secondary outcome measures were the number of post-operative complications per patient

  30 days (plus or minus 5 days)

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Intervention group will receive hydroxyethylstarch 6% bolus in order to minimize and maintain PVI below 14 %.

Other: Intervention group

Control group

NO INTERVENTION

Control group will receive fluid at the discretion of the anesthetist

Interventions

Intervention group OTHER

Control group will receive per-operative fluid at the discretion of the anesthetist, whereas Intervention group will receive additional hydroxyethylstarch 6% (HES) bolus in order to minimize and maintain PVI below 14 %. This PVI cut-off value was chosen according to previous reports \[Cannesson et al., 2008; Zimmermann et al., 2010\]. During the postoperative period, both groups were managed by intensivists (in the ICU) and clinicians (in the wards) not involved in the intraoperative management or in data collection. These individuals were not informed of patient allocation.

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults patients underwent high-risk surgery
• obtained the written informed consent
• patients under general anesthesia and mechanical ventilation

You may not qualify if:

• Patients with cardiac arrhythmias
• Patients \< 18 years
• Patients with a body mass index \> 40
• Patients undergoing surgery with an open thorax, neurosurgery or emergency surgery

Sponsors & Collaborators

• Hospital Regional de Presidente Prudente: lead

Study Sites (1)

Hospital Regional de Presidente Prudente

Presidente Prudente, São Paulo, 19050-680, Brazil

Location

Study Officials

• Edmundo P Souza Neto, PhD, MD

  Hospital Regional de Presidente Prudente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professeur, MD

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 11, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

BR (1)