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

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ClinicalTrials.gov Identifier: NCT01403909
Recruitment Status : Withdrawn (We need somebody to replace the principal inestigator.)
First Posted : July 27, 2011
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease Intervention/treatment Phase
Major Abdominal Surgery Device: Intermittent pneumatic compression Procedure: Standard care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Hypotensive episodes [ Time Frame: end of surgery (expected mean of 2 hours) ]
    The number of arterial hypotension episodes (systolic pressure < 90 mmHg)

  2. VEGF [ Time Frame: end of surgery (expected mean of 2 hours) ]
    Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood

  3. sFlt1 [ Time Frame: end of surgery (expected mean of 2 hours) ]
    Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood

  4. Hematocrit % [ Time Frame: end of surgery (expected mean of 2 hours) ]
  5. Albumin [ Time Frame: end of surgery (expected mean of 2 hours) ]
    Albuminemia (g/l)

  6. Prothrombin (%) [ Time Frame: end of surgery (expected mean of 2 hours) ]
    Prothrombin rate in blood

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

  8. Presence/absence of POSSUM complications [ Time Frame: 28 days ]
    Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria

  9. Days of hospitalization [ Time Frame: 28 days ]
    Length of hospitalization (days)

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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: RCB number )
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015