Major Abdominal SurgeryNCT01403909
Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery
A study testing Intermittent pneumatic compression in people with Major Abdominal Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Intermittent pneumatic compression
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient with ASA score 1-3
- Body mass index < 30 kg/m^2
- Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)
- The patient passes from home, directly to the hospital, without schelduled hospitalization in another department
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
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- The patient is breastfeeding
- The patient has a contra-indication for treatment necessary for the study
- ASA score > 3
- body mass index > 30 kg/m^2
- Expected surgical time of < 120 minutes
- Surgery with risk of hemorrhage
- Surgery via celioscopy
- The surgery require perineal access, thus rendering any blinding impossible
- Hepatic surgery
- Contra indication for intermittent venous compression
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients
The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.
- Conditions
- Major Abdominal Surgery
- Being tested
- Intermittent pneumatic compression, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic compressionDevice
Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
Standard careProcedure or surgery
Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.
| Study group | Role | What they receive |
|---|---|---|
| With compression | Experimental | The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery. Receives: Device: Intermittent pneumatic compression |
| Without compression | Active comparator | The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care) Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume fluids (ml)
The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)
Measured: End of surgery (expected mean of 2 hours)
Secondary outcomes (10)
Hypotensive episodes
The number of arterial hypotension episodes (systolic pressure < 90 mmHg)
Measured: end of surgery (expected mean of 2 hours)
VEGF
Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood
Measured: end of surgery (expected mean of 2 hours)
sFlt1
Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood
Measured: end of surgery (expected mean of 2 hours)
Hematocrit %
Measured: end of surgery (expected mean of 2 hours)
Albumin
Albuminemia (g/l)
Measured: end of surgery (expected mean of 2 hours)
Prothrombin (%)
Prothrombin rate in blood
Measured: end of surgery (expected mean of 2 hours)
Activated partial thromboplastin time
Activated partial thromboplastin time (seconds)
Measured: end of surgery (expected mean of 2 hours)
Presence/absence of POSSUM complications
Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria
Measured: 28 days
Days of hospitalization
Length of hospitalization (days)
Measured: 28 days
Number of days not in hospital
Number of days not in hospital
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startNov 2014
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: We need somebody to replace the principal inestigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Candela, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01403909
- Sponsor's protocol ID
- LOCAL/2011/DC-04
- Other IDs
- 2011-A00800-41
- Status last verified
- Mar 2015
- First submitted
- 26 Jul 2011
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients
- ClinicalTrials.gov ID
- NCT01403909
- Acronym / sponsor ID
- LOCAL/2011/DC-04
- Conditions
- Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We need somebody to replace the principal inestigator.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 27 Jul 2011 (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.
The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With compression | Experimental | Device: Intermittent pneumatic compressionThe patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery. |
| Without compression | Active comparator | Procedure: Standard careThe patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Patient with ASA score 1-3
- Body mass index < 30 kg/m^2
- Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)
Key exclusion criteria (16 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Intermittent pneumatic compressionIntermittent pneumatic venous compression is applied to the lower limbs of patients during surgery. | Device | With compression |
| Standard careIntermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery. | Procedure or surgery | Without compression |
Primary outcome
Volume fluids (ml)
Time frame: End of surgery (expected mean of 2 hours)
The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)
10 secondary outcomes
Hypotensive episodes
Time frame: end of surgery (expected mean of 2 hours)
VEGF
Time frame: end of surgery (expected mean of 2 hours)
sFlt1
Time frame: end of surgery (expected mean of 2 hours)
Hematocrit %
Time frame: end of surgery (expected mean of 2 hours)
Albumin
Time frame: end of surgery (expected mean of 2 hours)
Prothrombin (%)
Time frame: end of surgery (expected mean of 2 hours)
Activated partial thromboplastin time
Time frame: end of surgery (expected mean of 2 hours)
Presence/absence of POSSUM complications
Time frame: 28 days
Days of hospitalization
Time frame: 28 days
Number of days not in hospital
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
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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.
Damien Candela, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent pneumatic compression in people with Major Abdominal Surgery, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 6 inclusion and 16 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: withdrawn, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Volume fluids (ml) (time frame: End of surgery (expected mean of 2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2015.