Perioperative Hemodynamic Optimization Using the NICOM Device
NCT ID: NCT01217151
Last Updated: 2012-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2011-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Usual treatment
Hemodynamic monitoring based on common practice
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
Hemodynamic monitoring
Hemodynamic monitoring based on the NICOM device
Interventions
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Hemodynamic monitoring
Hemodynamic monitoring based on the NICOM device
Usual treatment
Hemodynamic monitoring based on common practice
Eligibility Criteria
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Inclusion Criteria
* Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
* Gastrectomy.
* Small bowel resection.
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
No
Sponsors
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University Hospital of the Nuestra Señora de Candelaria
OTHER
Hospital del Rio Hortega
OTHER
Hospital General de Ciudad Real
OTHER
University of Valencia
OTHER
Carmel Medical Center
OTHER
Hospital Universitario La Paz
OTHER
Responsible Party
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Hospital Universitario La Paz
Principal Investigators
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David Pestaña, M.D. Ph.D
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz
Locations
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Carmel Medical Center
Haifa, , Israel
Hospital General
Ciudad Real, , Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, , Spain
Hospital Universitario Río Hortega
Valladolid, , Spain
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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GDT NICOM
Identifier Type: -
Identifier Source: org_study_id