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

This study has been withdrawn prior to enrollment.
(We need somebody to replace the principal inestigator.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01403909
First received: July 26, 2011
Last updated: August 8, 2014
Last verified: August 2014

July 26, 2011
August 8, 2014
November 2014
November 2015   (final data collection date for primary outcome measure)
Volume fluids (ml) [ Time Frame: End of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)
Same as current
Complete list of historical versions of study NCT01403909 on ClinicalTrials.gov Archive Site
  • Hypotensive episodes [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: Yes ]
    The number of arterial hypotension episodes (systolic pressure < 90 mmHg)
  • VEGF [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood
  • sFlt1 [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood
  • Hematocrit % [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
  • Albumin [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Albuminemia (g/l)
  • Prothrombin (%) [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Prothrombin rate in blood
  • Activated partial thromboplastin time [ Time Frame: end of surgery (expected mean of 2 hours) ] [ Designated as safety issue: No ]
    Activated partial thromboplastin time (seconds)
  • Presence/absence of POSSUM complications [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria
  • Days of hospitalization [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Length of hospitalization (days)
  • Number of days not in hospital [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Number of days not in hospital
Same as current
Not Provided
Not Provided
 
Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Major Abdominal Surgery
  • Device: Intermittent pneumatic compression
    Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
  • Procedure: Standard care
    Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.
  • Experimental: With compression
    The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.
    Intervention: Device: Intermittent pneumatic compression
  • Active Comparator: Without compression
    The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)
    Intervention: Procedure: Standard care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2015
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01403909
LOCAL/2011/DC-04, 2011-A00800-41
Yes
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Damien Candela, MD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP