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Perioperative Hemodynamic Optimization Using the NICOM Device

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ClinicalTrials.gov Identifier: NCT01217151
Recruitment Status : Completed
First Posted : October 8, 2010
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
University Hospital of the Nuestra Señora de Candelaria
Hospital del Río Hortega
Hospital General de Ciudad Real
University of Valencia
Carmel Medical Center
Information provided by:
Hospital Universitario La Paz

Brief 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.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Device: Hemodynamic monitoring Other: Usual treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

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Arm Intervention/treatment
Sham Comparator: Usual treatment
The hemodynamic management will be performed according to the institution's standard of care, using fluids at the discretion of the anesthesiologist and the ICU specialist.
Other: Usual treatment
Hemodynamic monitoring based on common practice

Active Comparator: NICOM

For volume replacement, crystalloids will be used following the standard procedure according to the anesthesiologist or ICU specialist. Mean arterial pressure and cardiac index will be assessed every 5 minutes, and a volume bolus (250 mL colloid in 10 minutes) will be used to achieve a:

  • Mean arterial pressure ≥ 65 mmHg (intra and postoperatively), AND
  • Cardiac index ≥ 2.5 L/min/m2 (intra and postoperatively).

If these cardiovascular parameters are not met after the first colloid infusion, a supplementary bolus will be added. In case of not achieving the target, additional colloid boluses and/or pharmacologic support (norepinephrine in case of persistent hypotension, dobutamine in case of low cardiac output) will be provided according to the protocol

Device: Hemodynamic monitoring
Hemodynamic monitoring based on the NICOM device




Primary Outcome Measures :
  1. Decrease in hospital length of stay [ Time Frame: Three months ]

Secondary Outcome Measures :
  1. Time to peristalsis recovery [ Time Frame: Three weeks ]
    Peristalsis shall be assessed by first flatus after abdominal surgery

  2. Incidence of wound infection [ Time Frame: Three weeks ]
  3. Incidence of anastomotic leaks [ Time Frame: Three weeks ]
  4. Any cause mortality [ Time Frame: Three months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients scheduled for:
  • Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
  • Gastrectomy.
  • Small bowel resection.
  • Signed written informed consent.

Exclusion Criteria:

  • Less than 18 years old.
  • Laparoscopic procedure.
  • Emergency surgery.
  • Intra-abdominal infection.
  • Patients not requiring ICU admission (patients should stay for at least the first day at the ICU).
  • Life expectancy lower than 60 days.
  • Disseminated malignancy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01217151


Locations
Israel
Carmel Medical Center
Haifa, Israel, 34362
Spain
Hospital General
Ciudad Real, Spain, 13005
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, Spain, 38010
Hospital Universitario Río Hortega
Valladolid, Spain, 47009
Sponsors and Collaborators
Hospital Universitario La Paz
University Hospital of the Nuestra Señora de Candelaria
Hospital del Río Hortega
Hospital General de Ciudad Real
University of Valencia
Carmel Medical Center
Investigators
Principal Investigator: David Pestaña, M.D. Ph.D Hospital Universitario La Paz

Publications:
Responsible Party: David Pestaña, Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT01217151     History of Changes
Other Study ID Numbers: GDT NICOM
First Posted: October 8, 2010    Key Record Dates
Last Update Posted: November 20, 2012
Last Verified: September 2010

Keywords provided by Hospital Universitario La Paz:
Hemodynamic Monitoring
Goal-Directed Therapy