Perioperative Hemodynamic Optimization Using the NICOM Device

NCT01217151 | Completed

• 1 other identifier: GDT NICOM
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 4

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.

Conditions

Major Abdominal Surgery

Keywords

Hemodynamic Monitoring; Goal-Directed Therapy

Outcome Measures

Primary Outcomes (1)

• Decrease in hospital length of stay

  Three months

Secondary Outcomes (4)

• Time to peristalsis recovery

  Three weeks

• Incidence of wound infection

  Three weeks

• Incidence of anastomotic leaks

  Three weeks

• Any cause mortality

  Three months

Study Arms (2)

Usual treatment

SHAM COMPARATOR

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

NICOM

ACTIVE COMPARATOR

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

Interventions

Hemodynamic monitoring DEVICE

Hemodynamic monitoring based on the NICOM device

NICOM

Usual treatment OTHER

Hemodynamic monitoring based on common practice

Usual treatment

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead
• University Hospital of the Nuestra Señora de Candelaria: collaborator
• Hospital del Rio Hortega: collaborator
• Hospital General de Ciudad Real: collaborator
• University of Valencia: collaborator
• Carmel Medical Center: collaborator

Study Sites (4)

Carmel Medical Center

Haifa, 34362, Israel

Location

Hospital General

Ciudad Real, 13005, Spain

Location

Hospital Universitario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Río Hortega

Valladolid, 47009, Spain

Location

Related Publications (5)

• 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.

  PMID: 19638227 BACKGROUND

• 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.

  PMID: 16356219 BACKGROUND

• 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.

  PMID: 17822565 BACKGROUND

• 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.

  PMID: 20553586 BACKGROUND

• 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.

  PMID: 12357146 BACKGROUND

MeSH Terms

Interventions

Hemodynamic Monitoring

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• David Pestaña, M.D. Ph.D

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: January 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 20, 2012

Record last verified: 2010-09

Locations

IL (1); ES (3)