Major Abdominal SurgeryNCT01217151
Perioperative Hemodynamic Optimization Using the NICOM Device
A study testing Hemodynamic monitoring and Usual treatment in people with Major Abdominal Surgery, run by Hospital Universitario La Paz at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Hemodynamic monitoring and Usual treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for:
- Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
- Gastrectomy.
- Small bowel resection.
- Signed written informed consent.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
Hospital General
Ciudad Real, 13005
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010
Hospital Universitario Río Hortega
Valladolid, 47009
About this study
Official title: Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery
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
- Being tested
- Hemodynamic monitoring, Usual treatment
- Keywords
- Hemodynamic Monitoring, Goal-Directed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic monitoringDevice
Hemodynamic monitoring based on the NICOM device
Usual treatmentOther
Hemodynamic monitoring based on common practice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Device: Hemodynamic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in hospital length of stay
Measured: Three months
Secondary outcomes (4)
Time to peristalsis recovery
Peristalsis shall be assessed by first flatus after abdominal surgery
Measured: Three weeks
Incidence of wound infection
Measured: Three weeks
Incidence of anastomotic leaks
Measured: Three weeks
Any cause mortality
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or 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
- Investigators
- David Pestaña, M.D. Ph.D, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217151
- Sponsor's protocol ID
- GDT NICOM
- Status last verified
- Sep 2010
- First submitted
- 7 Oct 2010
- Last updated
- 20 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19638227Pearse 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.
PubMed 16356219Lopes 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.
PubMed 17822565Benes 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.
PubMed 20553586Gan 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.
PubMed 12357146
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Hemodynamic Goal-directed Optimization Using the Noninvasive NICOM™ Monitoring Device in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT01217151
- Acronym / sponsor ID
- GDT NICOM
- Conditions
- Major Abdominal Surgery
- Keywords
- Hemodynamic Monitoring, Goal-Directed Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or 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
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual treatment | Sham comparator | Other: Usual treatmentThe 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 monitoringFor 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients scheduled for:
- Open colorectal surgery: hemicolectomy, pancolectomy, abdomino-perineal resection.
- Gastrectomy.
- Small bowel resection.
- Signed written informed consent.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodynamic monitoringHemodynamic monitoring based on the NICOM device | Device | NICOM |
| Usual treatmentHemodynamic monitoring based on common practice | Other | Usual treatment |
Primary outcome
Decrease in hospital length of stay
Time frame: Three months
4 secondary outcomes
Time to peristalsis recovery
Time frame: Three weeks
Incidence of wound infection
Time frame: Three weeks
Incidence of anastomotic leaks
Time frame: Three weeks
Any cause mortality
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2012.
- Background: PubMed 19638227Squara 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.
- Background: PubMed 16356219Pearse 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.
- Background: PubMed 17822565Lopes 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.
- Background: PubMed 20553586Benes 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.
- Background: PubMed 12357146Gan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pestaña, M.D. Ph.D principal investigator
Hospital Universitario La Paz
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic monitoring and Usual treatment in people with Major Abdominal Surgery, run by Hospital Universitario La Paz at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in hospital length of stay (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01217151, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2012.