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

NCT01403909 | Withdrawn DMC

• 2 other identifiers: LOCAL/2011/DC-042011-A00800-41
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Volume fluids (ml)

  The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)

  End of surgery (expected mean of 2 hours)

Secondary Outcomes (10)

• Hypotensive episodes

  end of surgery (expected mean of 2 hours)

• VEGF

  end of surgery (expected mean of 2 hours)

• sFlt1

  end of surgery (expected mean of 2 hours)

• Hematocrit %

  end of surgery (expected mean of 2 hours)

• Albumin

  end of surgery (expected mean of 2 hours)

Study Arms (2)

With compression

EXPERIMENTAL

The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.

Device: Intermittent pneumatic compression

Without compression

ACTIVE COMPARATOR

The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)

Procedure: Standard care

Interventions

Intermittent pneumatic compression DEVICE

Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.

With compression

Standard care PROCEDURE

Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.

Without compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• The patient is participating in another 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

MeSH Terms

Interventions

Intermittent Pneumatic Compression Devices; Standard of Care

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Damien Candela, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: November 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

FR (1)