Clinical trial NCT01403909: Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Abdominal Surgery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Volume fluids (ml)
timeFrame: End of surgery (expected mean of 2 hours)
Secondary outcomes:
measure: Hypotensive episodes
timeFrame: end of surgery (expected mean of 2 hours)
measure: VEGF
timeFrame: end of surgery (expected mean of 2 hours)
measure: sFlt1
timeFrame: end of surgery (expected mean of 2 hours)
measure: Hematocrit %
timeFrame: end of surgery (expected mean of 2 hours)
measure: Albumin
timeFrame: end of surgery (expected mean of 2 hours)
measure: Prothrombin (%)
timeFrame: end of surgery (expected mean of 2 hours)
measure: Activated partial thromboplastin time
timeFrame: end of surgery (expected mean of 2 hours)
measure: Presence/absence of POSSUM complications
timeFrame: 28 days
measure: Days of hospitalization
timeFrame: 28 days
measure: Number of days not in hospital
timeFrame: 28 days
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Damien Candela, MD
role: PRINCIPAL_INVESTIGATOR
References: