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Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)

This study has been completed.
Sponsor:
Collaborator:
The Danish Medical Research Council
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00364741
First received: August 15, 2006
Last updated: October 15, 2009
Last verified: October 2009
History of Changes
  Purpose

Aim: To investigate the effect of high intra- and postoperative oxygen concentration (80%, as opposed to normally 30%) on surgical wound infection and pulmonary complications after abdominal surgery.

Background: Surgical wound infection is a common and serious complication. Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils. Oxygen is a substrate in this reaction, and it is hypothesized that by increasing the arterial oxygen tension, the risk of surgical wound infection is reduced. Previous studies to test this hypothesis have shown entirely different results. Hence, the clinical decision between high and normal oxygen concentration is still controversial.

Primary hypothesis of study: Use of 80% oxygen decreases the incidence of surgical wound infection after abdominal surgery.

Secondary objectives: To investigate the effect 80% oxygen on pulmonary complications (atelectasis, pneumonia, respiratory insufficiency), second operation, mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery.


Condition Intervention Phase
Laparotomy
 Drug: Oxygen
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery (The PROXI-trial)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Surgical wound infection [ Time Frame: 14 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Atelectasis, pneumonia, respiratory insufficiency, second operation, mortality, length of postoperative hospitalization, admission to intensive care unit. [ Time Frame: 30 days after surgery ] [ Designated as safety issue: Yes ]

Enrollment: 1400
Study Start Date: October 2006
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Fraction of inspired oxygen (FiO2) = 0.30
 Drug: Oxygen
During and 2 hours after surgery
Active Comparator: B
FiO2 = 0.80
 Drug: Oxygen
During and 2 hours after surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older.
  • Laparotomy, acute or elective. In case of gynaecological surgery only if malignancy is suspected (defined as risk of ovarian malignancy index >200 or a specimen with atypical or neoplastic cells).

Exclusion Criteria:

  • Other surgery within 30 days (except surgery in local anaesthesia).
  • Chemotherapy within 3 months.
  • Inability to give informed consent.
  • Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364741

Locations
Denmark
Aarhus Sygehus
Aarhus, Denmark, DK-8000
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100
Copenhagen University Hospital, Amager
Copenhagen, Denmark, DK-2300
Copenhagen University Hospital, Bispebjerg
Copenhagen, Denmark, DK-2400
Copenhagen University Hospital, Gentofte
Hellerup, Denmark, DK-2900
Copenhagen University Hospital, Herlev
Herlev, Denmark, DK-2730
Holbaek Hospital
Holbaek, Denmark, DK-4300
Kolding Hospital
Kolding, Denmark, DK-6000
Naestved Hospital
Naestved, Denmark, DK-4700
Nykoebing Falster Hospital
Nykoebing Falster, Denmark, DK-4800
Slagelse Hospital
Slagelse, Denmark, DK-4200
Funen County Hospital
Svendborg, Denmark, DK-5700
Vejle Hospital
Vejle, Denmark, DK-7100
Viborg Hospital
Viborg, Denmark, DK-8800
Sponsors and Collaborators
Rigshospitalet, Denmark
The Danish Medical Research Council
Investigators
Study Chair: Lars S. Rasmussen, MD,DMSc,PHD Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Jørn Wetterslev, MD, PHD Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Study Director: Lars N. Jørgensen, MD, DMSc Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark
Principal Investigator: Christian S. Meyhoff, MD, PhD Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
  More Information

Publications:

Responsible Party: Lars S. Rasmussen, Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet
ClinicalTrials.gov Identifier: NCT00364741     History of Changes
Other Study ID Numbers: 2006-001710-32, GCP-2006-101, KF 02 306766
Study First Received: August 15, 2006
Last Updated: October 15, 2009
Health Authority: Denmark: National Board of Health

ClinicalTrials.gov processed this record on May 21, 2013