Clinical trial NCT01217151: Perioperative Hemodynamic Optimization Using the NICOM Device
Official title: Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Abdominal Surgery
Keywords: Hemodynamic Monitoring
Goal-Directed Therapy
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: University Hospital of the Nuestra Señora de Candelaria
name: Hospital del Rio Hortega
name: Hospital General de Ciudad Real
name: University of Valencia
name: Carmel Medical Center
First posted: 2010-10-08
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Decrease in hospital length of stay
timeFrame: Three months
Secondary outcomes:
measure: Time to peristalsis recovery
timeFrame: Three weeks
measure: Incidence of wound infection
timeFrame: Three weeks
measure: Incidence of anastomotic leaks
timeFrame: Three weeks
measure: Any cause mortality
timeFrame: Three months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Ciudad Real
country: Spain
facility: Hospital General
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario Nuestra Señora de la Candelaria
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: Hospital Universitario La Paz
name: David Pestaña, M.D. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Squara P, Rotcajg D, Denjean D, Estagnasie P, Brusset A. Comparison of monitoring performance of Bioreactance vs. pulse contour during lung recruitment maneuvers. Crit Care. 2009;13(4):R125. doi: 10.1186/cc7981. Epub 2009 Jul 28.
citation: Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445]. Crit Care. 2005;9(6):R687-93. doi: 10.1186/cc3887. Epub 2005 Nov 8.
citation: Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
citation: Benes J, Chytra I, Altmann P, Hluchy M, Kasal E, Svitak R, Pradl R, Stepan M. Intraoperative fluid optimization using stroke volume variation in high risk surgical patients: results of prospective randomized study. Crit Care. 2010;14(3):R118. doi: 10.1186/cc9070. Epub 2010 Jun 16.
citation: Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002 Oct;97(4):820-6. doi: 10.1097/00000542-200210000-00012.