Perioperative Hemodynamic Optimization Using the NICOM Device
- Conditions
- Major Abdominal Surgery
- Interventions
- Other: Usual treatmentDevice: Hemodynamic monitoring
- Registration Number
- NCT01217151
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 142
- Adult patients scheduled for:
- Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
- Gastrectomy.
- Small bowel resection.
- Signed written informed consent.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual treatment 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. NICOM Hemodynamic monitoring 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
- Primary Outcome Measures
Name Time Method Decrease in hospital length of stay Three months
- Secondary Outcome Measures
Name Time Method Incidence of wound infection Three weeks Time to peristalsis recovery Three weeks Peristalsis shall be assessed by first flatus after abdominal surgery
Incidence of anastomotic leaks Three weeks Any cause mortality Three months
Trial Locations
- Locations (4)
Carmel Medical Center
🇮🇱Haifa, Israel
Hospital General
🇪🇸Ciudad Real, Spain
Hospital Universitario Río Hortega
🇪🇸Valladolid, Spain
Hospital Universitario Nuestra Señora de la Candelaria
🇪🇸Santa Cruz de Tenerife, Spain