Perioperative Hemodynamic Optimization Using the NICOM Device

Major Abdominal Surgery Clinical Trial

Official title:

Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01217151
• Other study ID #: GDT NICOM
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: November 19, 2012
• Start date: January 2011
• Est. completion date: November 2012

Study information

• Verified date: September 2010
• Source: Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Major Abdominal Surgery

Intervention

Device:
• Hemodynamic monitoring
Hemodynamic monitoring based on the NICOM device

Other:
• Usual treatment
Hemodynamic monitoring based on common practice

Locations

Country	Name	City	State
Israel	Carmel Medical Center	Haifa
Spain	Hospital General	Ciudad Real
Spain	Hospital Universitario Nuestra Señora de la Candelaria	Santa Cruz de Tenerife
Spain	Hospital Universitario Río Hortega	Valladolid

Sponsors (6)

Lead Sponsor	Collaborator
Hospital Universitario La Paz	Carmel Medical Center, Hospital del Río Hortega, Hospital General de Ciudad Real, University Hospital of the Nuestra Señora de Candelaria, University of Valencia

Countries where clinical trial is conducted

Israel,  Spain, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2005 Nov 8. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in hospital length of stay		Three months	No
Secondary	Time to peristalsis recovery	Peristalsis shall be assessed by first flatus after abdominal surgery	Three weeks	No
Secondary	Incidence of wound infection		Three weeks	No
Secondary	Incidence of anastomotic leaks		Three weeks	No
Secondary	Any cause mortality		Three months	No