Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery
| Registry | NCT01217151 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 142 (Actual) |
| Sponsor | Hospital Universitario La Paz (Other); collaborators: University Hospital of the Nuestra Señora de Candelaria, Hospital del Rio Hortega, Hospital General de Ciudad Real, University of Valencia, Carmel Medical Center |
| Conditions | Major Abdominal Surgery |
| Interventions | Hemodynamic monitoring, Usual treatment (Device, other) |
| Dates | start 2011-01-01, primary completion 2012-11-01, completion 2012-11-01, first posted 2010-10-08, last updated 2012-11-20 |
| Locations | 4 sites in Israel, Spain |
Related Papers Related Patents Related Grants Related Experts
All trials for Major Abdominal Surgery All trials of Hemodynamic monitoring All trials of Usual treatment
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Usual treatment | Sham comparator | Other: 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 | Active comparator | Device: 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 |
Sex: All, ages: 18 Years to 90 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| 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 |