Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial)
NCT ID: NCT00364741
Last Updated: 2009-10-16
Study Results
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Basic Information
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COMPLETED
PHASE4
1400 participants
INTERVENTIONAL
2006-10-31
2008-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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A
Fraction of inspired oxygen (FiO2) = 0.30
Oxygen
During and 2 hours after surgery
B
FiO2 = 0.80
Oxygen
During and 2 hours after surgery
Interventions
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Oxygen
During and 2 hours after surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* Chemotherapy within 3 months.
* Inability to give informed consent.
* Inability to keep oxygen saturation above 90% without supplemental oxygen (measured preoperatively by pulse oximetry).
18 Years
ALL
No
Sponsors
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The Danish Medical Research Council
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Department of Anaesthesia, HOC, Copenhagen University Hospital, Rigshospitalet
Principal Investigators
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Lars S. Rasmussen, MD,DMSc,PHD
Role: STUDY_CHAIR
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Jørn Wetterslev, MD, PHD
Role: STUDY_DIRECTOR
Copenhagen Trial Unit, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Lars N. Jørgensen, MD, DMSc
Role: STUDY_DIRECTOR
Dept. of Surgery, Copenhagen University Hospital, Bispebjerg, Copenhagen, Denmark
Christian S. Meyhoff, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark
Locations
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Aarhus Sygehus
Aarhus, , Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Copenhagen University Hospital, Amager
Copenhagen, , Denmark
Copenhagen University Hospital, Bispebjerg
Copenhagen, , Denmark
Copenhagen University Hospital, Gentofte
Hellerup, , Denmark
Copenhagen University Hospital, Herlev
Herlev, , Denmark
Holbaek Hospital
Holbæk, , Denmark
Kolding Hospital
Kolding, , Denmark
Nykoebing Falster Hospital
Nykoebing Falster, , Denmark
Naestved Hospital
Næstved, , Denmark
Slagelse Hospital
Slagelse, , Denmark
Funen County Hospital
Svendborg, , Denmark
Vejle Hospital
Vejle, , Denmark
Viborg Hospital
Viborg, , Denmark
Countries
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References
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Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Simonsen I, Pulawska T, Walker LR, Skovgaard N, Helto K, Gocht-Jensen P, Carlsson PS, Rask H, Karim S, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial. Trials. 2008 Oct 22;9:58. doi: 10.1186/1745-6215-9-58.
Meyhoff CS, Wetterslev J, Jorgensen LN, Henneberg SW, Hogdall C, Lundvall L, Svendsen PE, Mollerup H, Lunn TH, Simonsen I, Martinsen KR, Pulawska T, Bundgaard L, Bugge L, Hansen EG, Riber C, Gocht-Jensen P, Walker LR, Bendtsen A, Johansson G, Skovgaard N, Helto K, Poukinski A, Korshin A, Walli A, Bulut M, Carlsson PS, Rodt SA, Lundbech LB, Rask H, Buch N, Perdawid SK, Reza J, Jensen KV, Carlsen CG, Jensen FS, Rasmussen LS; PROXI Trial Group. Effect of high perioperative oxygen fraction on surgical site infection and pulmonary complications after abdominal surgery: the PROXI randomized clinical trial. JAMA. 2009 Oct 14;302(14):1543-50. doi: 10.1001/jama.2009.1452.
Other Identifiers
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GCP-2006-101
Identifier Type: -
Identifier Source: secondary_id
KF 02 306766
Identifier Type: -
Identifier Source: secondary_id
2006-001710-32
Identifier Type: -
Identifier Source: org_study_id
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