Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01403909
• Date of registration: 26/07/2011
• Prospective Registration: Yes
• Primary sponsor: Centre Hospitalier Universitaire de Nimes
• Public title: Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery
• Scientific 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
• Date of first enrolment: November 2014
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01403909
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Damien Candela, MD
• Affiliation: Centre Hospitalier Universitaire de Nîmes

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Major Abdominal Surgery

Intervention(s)

Device: Intermittent pneumatic compression

Procedure: Standard care

Primary Outcome(s)

Volume fluids (ml) [Time Frame: End of surgery (expected mean of 2 hours)]

Secondary Outcome(s)

Albumin [Time Frame: end of surgery (expected mean of 2 hours)]

Hematocrit % [Time Frame: end of surgery (expected mean of 2 hours)]

Prothrombin (%) [Time Frame: end of surgery (expected mean of 2 hours)]

Days of hospitalization [Time Frame: 28 days]

Hypotensive episodes [Time Frame: end of surgery (expected mean of 2 hours)]

Presence/absence of POSSUM complications [Time Frame: 28 days]

sFlt1 [Time Frame: end of surgery (expected mean of 2 hours)]

VEGF [Time Frame: end of surgery (expected mean of 2 hours)]

Activated partial thromboplastin time [Time Frame: end of surgery (expected mean of 2 hours)]

Number of days not in hospital [Time Frame: 28 days]

Secondary ID(s)

2011-A00800-41

LOCAL/2011/DC-04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors