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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention
Major Abdominal Surgery
Device: Intermittent pneumatic compression
Procedure: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: November 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: With compression
The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.
Device: Intermittent pneumatic compression
Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
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)
Procedure: Standard care
Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403909

Locations
France
Centre Hospitalier Universitaire de Nîmes
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Damien Candela, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01403909     History of Changes
Other Study ID Numbers: LOCAL/2011/DC-04, 2011-A00800-41
Study First Received: July 26, 2011
Last Updated: August 8, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

ClinicalTrials.gov processed this record on September 30, 2014