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Perioperative Hemodynamic Optimization Using the NICOM Device

NCT01217151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2012-11-20

No results posted yet for this study

Summary

In the last years, there is a growing interest in the improvement of prognosis and shortening of hospital length of stay in high-risk surgical patients. Several evidence-based protocols ("fast-track" surgery) have been developed and implemented in some hospitals for this purpose. Cardiovascular optimization through the so-called "goal-directed therapy" (GDT) is a key element in these protocols. Previous studies in the literature use invasive monitors to assess hemodynamics. The NICOM ™ is a non-invasive monitor validated in several clinical scenarios. The aim of the present randomized, international, multi-center, open-label clinical trial is to use a GDT protocol (including colloid boluses and vasoactive drug infusion) based on data obtained from the NICOM™ device (cardiac index and mean arterial pressure) to test the hypothesis that GDT is superior to standard practice in terms of reduction in the incidence of perioperative complications and length of hospital stay in high-risk major abdominal surgery patients (requiring ICU surveillance for, at least, 24 hours). As secondary objectives, time to first flatus, wound infection, anastomotic leaks and mortality will be analysed. All patients will be followed from the day of surgery up to hospital discharge (determined by a specialist surgeon not involved in the study) or death.

Conditions

  • Major Abdominal Surgery

Interventions

DEVICE

Hemodynamic monitoring

Hemodynamic monitoring based on the NICOM device

OTHER

Usual treatment

Hemodynamic monitoring based on common practice

Sponsors & Collaborators

  • University Hospital of the Nuestra Señora de Candelaria

    collaborator OTHER

  • Hospital del Rio Hortega

    collaborator OTHER

  • Hospital General de Ciudad Real

    collaborator OTHER

  • University of Valencia

    collaborator OTHER

  • Carmel Medical Center

    collaborator OTHER

  • Hospital Universitario La Paz

    lead OTHER

Principal Investigators

  • David Pestaña, M.D. Ph.D · Hospital Universitario La Paz

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Israel
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217151 on ClinicalTrials.gov